Cystoscopy Infection Lawsuit

Cystoscopes are reusable scopes that are used in bladder and urological procedures. If the scope is not adequately sanitized between uses, patients can develop infections and other serious complications.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting cystoscopy infection cases in all 50 states. If you or a loved one developed a serious infection, sepsis, or other complication after a cystoscopy procedure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Overview: What is Cystoscopy And Why Is It Used?

Cystoscopy is a medical procedure that is used to diagnose and treat bladder and urinary tract problems. During the procedure, a doctor inserts a specialized scope into the patient’s urethra to view the inside of the urinary tract and/or bladder.

The scope looks like a long, thin, flexible tube with a camera and a light on the end. It helps doctors diagnose and treat conditions like blood in the urine, unexplained pain during urniation, leaking, bladder stones, prostate problems, bladder cancer, and more.

What is the Problem?

Reusable cystoscopes are used on multiple patients, so they must be sanitized to prevent the scope from spreading biological material from one patient to another. This cleaning procedure is called “reprocessing,” and it is a strict multi-step process involving pre-cleaning, leak testing, scrubbing, disinfection, rinsing, drying, and storage.

Unfortunately, even when hospitals follow the reprocessing steps exactly, cystoscopes may still be contaminated. In a study published in 2025, researchers found that cystoscope contamination rates are realtively high, from 2 to 21% and infections may go unreported and undetected.

FDA Recalls Olympus Cystoscope Accessory After 120 Injuries and 1 Death

In December 2024, Olympus sent hospitals an Medical Device Advisory Notice about the MAJ-891 Forceps/Irrigation Plug “related to the risk of device contamination,” including reports of infections and 1 patient death.

Olympus urged hospitals to use alternative endoscopes or non-Olympus irrigation plugs if possible, and warned:

“Olympus assessed the issue after receiving complaints of adverse events involving patient injuries and one death. The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, which could result in patient injury, specifically, infection.”

The FDA also announced the warning in January 2025 to warn healthcare facilities about the “risk of device contamination that may result from improper reprocessing.”

Olympus Scopes Linked to 120 Injuries and 1 Death Due to Infection

In March 2025, the FDA issued an Update on Alert for the MAJ-891 Forceps/Irrigation Plug. According to the FDA:

“Olympus has reported 120 injuries and 1 report of death due to infection following procedures in which the MAJ-891 was used with a cystoscope (CYF scope).”

The FDA also warned about the serious risks associated with contaminated scopes, which could include “infection, urinary tract infection, or sepsis, and, in some cases, could result in death. These harms may require inpatient hospitalization/monitoring, and treatment with oral or intravenous antibiotics.”

How Many Infections Have Been Reported?

During a 4-year timeline between January 2017 and February 2021, the FDA sadi it received more than 450 reports of infections, deaths, or persistent scope contamination issues associated with reprocessed urological endoscopes, including cystoscopes and uretoeroscopes. Three of those reports involved patient deaths, all outside the U.S., and all of the deaths involved Olympus scopes.

What Infections Have Been Linked to Contaminated Cystoscopes?

Urinary tract infection, including recurrent and treatment-resistant UTI
Pseudomonas aeruginosa
Escherichia coli (E. coli)
Carbapenem-resistant Enterobacterales (CRE), often called a “superbug”
Vancomycin-resistant Enterococcus (VRE)
Bacteremia and other bloodstream infections
Urosepsis, sepsis, and septic shock
Pyelonephritis and kidney damage
Prostatitis and epididymitis

Karl Storz Recalls Urological Scopes to Update Reprocessing Instructions

In 2022, Karl Storz announced a Class II recall for certain flexible urological endoscopes, including cystoscopes and cystourethroscopes. The company instructed customers to stop all high-level disinfection methods for the recalled scopes and sterilize them after each use instead.

Types of Cystoscopes and Components

Olympus MAJ-891 Forceps/Irrigation Plug, all lots, UDI 04953170063114, the subject of the FDA’s most serious recall classification
Olympus CYF series flexible cystoscopes and cysto-nephroscopes, including the CYF-240, CYF-5, CYF-5A, CYF-5R, CYF-V2, CYF-V2R, CYF-VA2, CYF-VH, CYF-VHA, and CYF-VHR
Olympus VISERA Cysto-Nephro Videoscope ENF-V2 and OES Uretero-Reno Fiberscope URF-P5, both named in the FDA’s June 2025 import alert
Karl Storz single channel flexible cystoscopes, cystourethroscopes, ureteroscopes, and ureterorenoscopes covered by the April 2022 recall

Who May Qualify to File a Cystoscopy Infection Lawsuit?

Our lawyers are evaluating claims involving any of these procedures performed from 2018 onward:

Cystoscopy
Ureteroscopy
Hysteroscopy
ERCP
Duodenoscope
Colonoscopy
Upper Endoscopy
Bronchoscopy
Laparoscopy
Sinus Endoscopy

The procedure must also have been followed by at least one of these serious injuries:

Diagnosis of a “superbug” or drug-resistant infection such as CRE or E. coli within 180 days of the procedure
Organ or tissue damage, or perforation
Dislodging or breaking of the endoscopic device
Severe bleeding or hemorrhaging that required hospitalization or a blood transfusion
Sepsis or bacteremia (blood infection)
Bacterial infection requiring hospitalization
Pneumonia or severe pulmonary infection
Tuberculosis within 90 days of the procedure
HIV diagnosis within 90 days of the procedure
Death from an infection, a “superbug,” or a component failure

Do I Have a Cystoscopy Lawsuit?

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