Olympus A02908ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761019507), received between Sep 27, 2024 and Sep 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Contamination” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem; Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) NOTICED AN INCREASED NUMBER OF URINARY TRACT INFECTIONS IN PATIENTS AFTER CYSTOSCOPY PROCEDURES WHEN THE FACILITY STARTED USING THE 3-WAY STOPCOCK ON FLEXIBLE CYSTOSCOPES. THERE WERE FOUR PATIENTS AFFECTED AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL THE WEEK AFTER THE PROCEDURE. THEY WERE DIAGNOSED WITH URINARY TRACT INFECTION AND SEPSIS. AT FIRST THE STOPCOCK DEVICES WERE REPROCESSED USING A THERMAL DISINFECTOR AND NOW THE FACILITY REPROCESSES THE DEVICE IN THE BASKET OF AN ETD4 REPROCESSOR. THE CUSTOMER INDICATED THEY HAD NO INSTRUCTIONS FOR MACHINE CLEANING THE STOPCOCK DEVICES. THE CYSTOSCOPES HAD A CLEAR AND PROVEN WASHING PROCESS THAT HAD NOT BEEN CHANGED. IT WAS WHEN THEY CHANGED TO THE NEW STOPCOCK DEVICE THAT THE URINARY TRACT INFECTIONS APPEARED, THEREFORE IT IS THE LIKELY SOURCE OF THE INFECTIONS. THE CUSTOMER INDICATED THEY DID NOT KNOW IF THE STOPCOCKS HAD BE CULTURED. ADDITIONAL INFORMATION REGARDING EACH INDIVIDUAL PATIENT OUTCOME WAS REQUESTED BUT UNKNOWN BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WERE FIVE STOPCOCKS INVOLVED, HOWEVER THEY COULD NOT TRACE WHICH STOPCOCK WAS USED FOR EACH OF THE FOUR INDIVIDUAL PAT

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 20323278 ↗
• InjurySep 27, 2024Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem; Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) NOTICED AN INCREASED NUMBER OF URINARY TRACT INFECTIONS IN PATIENTS AFTER CYSTOSCOPY PROCEDURES WHEN THE FACILITY STARTED USING THE 3-WAY STOPCOCK ON FLEXIBLE CYSTOSCOPES. THERE WERE FOUR PATIENTS AFFECTED AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL THE WEEK AFTER THE PROCEDURE. THEY WERE DIAGNOSED WITH URINARY TRACT INFECTION AND SEPSIS. AT FIRST THE STOPCOCK DEVICES WERE REPROCESSED USING A THERMAL DISINFECTOR AND NOW THE FACILITY REPROCESSES THE DEVICE IN THE BASKET OF AN ETD4 REPROCESSOR. THE CUSTOMER INDICATED THEY HAD NO INSTRUCTIONS FOR MACHINE CLEANING THE STOPCOCK DEVICES. THE CYSTOSCOPES HAD A CLEAR AND PROVEN WASHING PROCESS THAT HAD NOT BEEN CHANGED. IT WAS WHEN THEY CHANGED TO THE NEW STOPCOCK DEVICE THAT THE URINARY TRACT INFECTIONS APPEARED, THEREFORE IT IS THE LIKELY SOURCE OF THE INFECTIONS. THE CUSTOMER INDICATED THEY DID NOT KNOW IF THE STOPCOCKS HAD BE CULTURED. ADDITIONAL INFORMATION REGARDING EACH INDIVIDUAL PATIENT OUTCOME WAS REQUESTED BUT UNKNOWN BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WERE FIVE STOPCOCKS INVOLVED, HOWEVER THEY COULD NOT TRACE WHICH STOPCOCK WAS USED FOR EACH OF THE FOUR INDIVIDUAL PAT

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 20323254 ↗
• InjurySep 27, 2024Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem; Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) NOTICED AN INCREASED NUMBER OF URINARY TRACT INFECTIONS IN PATIENTS AFTER CYSTOSCOPY PROCEDURES WHEN THE FACILITY STARTED USING THE 3-WAY STOPCOCK ON FLEXIBLE CYSTOSCOPES. THERE WERE FOUR PATIENTS AFFECTED AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL THE WEEK AFTER THE PROCEDURE. THEY WERE DIAGNOSED WITH URINARY TRACT INFECTION AND SEPSIS. AT FIRST THE STOPCOCK DEVICES WERE REPROCESSED USING A THERMAL DISINFECTOR AND NOW THE FACILITY REPROCESSES THE DEVICE IN THE BASKET OF AN ETD4 REPROCESSOR. THE CUSTOMER INDICATED THEY HAD NO INSTRUCTIONS FOR MACHINE CLEANING THE STOPCOCK DEVICES. THE CYSTOSCOPES HAD A CLEAR AND PROVEN WASHING PROCESS THAT HAD NOT BEEN CHANGED. IT WAS WHEN THEY CHANGED TO THE NEW STOPCOCK DEVICE THAT THE URINARY TRACT INFECTIONS APPEARED, THEREFORE IT IS THE LIKELY SOURCE OF THE INFECTIONS. THE CUSTOMER INDICATED THEY DID NOT KNOW IF THE STOPCOCKS HAD BE CULTURED. ADDITIONAL INFORMATION REGARDING EACH INDIVIDUAL PATIENT OUTCOME WAS REQUESTED BUT UNKNOWN BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WERE FIVE STOPCOCKS INVOLVED, HOWEVER THEY COULD NOT TRACE WHICH STOPCOCK WAS USED FOR EACH OF THE FOUR INDIVIDUAL PAT

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 20323237 ↗
• InjurySep 27, 2024Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem; Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) NOTICED AN INCREASED NUMBER OF URINARY TRACT INFECTIONS IN PATIENTS AFTER CYSTOSCOPY PROCEDURES WHEN THE FACILITY STARTED USING THE 3-WAY STOPCOCK ON FLEXIBLE CYSTOSCOPES. THERE WERE FOUR PATIENTS AFFECTED AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL THE WEEK AFTER THE PROCEDURE. THEY WERE DIAGNOSED WITH URINARY TRACT INFECTION AND SEPSIS. AT FIRST THE STOPCOCK DEVICES WERE REPROCESSED USING A THERMAL DISINFECTOR AND NOW THE FACILITY REPROCESSES THE DEVICE IN THE BASKET OF AN ETD4 REPROCESSOR. THE CUSTOMER INDICATED THEY HAD NO INSTRUCTIONS FOR MACHINE CLEANING THE STOPCOCK DEVICES. THE CYSTOSCOPES HAD A CLEAR AND PROVEN WASHING PROCESS THAT HAD NOT BEEN CHANGED. IT WAS WHEN THEY CHANGED TO THE NEW STOPCOCK DEVICE THAT THE URINARY TRACT INFECTIONS APPEARED, THEREFORE IT IS THE LIKELY SOURCE OF THE INFECTIONS. THE CUSTOMER INDICATED THEY DID NOT KNOW IF THE STOPCOCKS HAD BE CULTURED. ADDITIONAL INFORMATION REGARDING EACH INDIVIDUAL PATIENT OUTCOME WAS REQUESTED BUT UNKNOWN BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WERE FIVE STOPCOCKS INVOLVED, HOWEVER THEY COULD NOT TRACE WHICH STOPCOCK WAS USED FOR EACH OF THE FOUR INDIVIDUAL PAT

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 20323177 ↗
• InjurySep 27, 2024Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem; Device Reprocessing Problem; Contamination; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) NOTICED AN INCREASED NUMBER OF URINARY TRACT INFECTIONS IN PATIENTS AFTER CYSTOSCOPY PROCEDURES WHEN THE FACILITY STARTED USING THE 3-WAY STOPCOCK ON FLEXIBLE CYSTOSCOPES. THERE WERE FOUR PATIENTS AFFECTED AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL THE WEEK AFTER THE PROCEDURE. THEY WERE DIAGNOSED WITH URINARY TRACT INFECTION AND SEPSIS. AT FIRST THE STOPCOCK DEVICES WERE REPROCESSED USING A THERMAL DISINFECTOR AND NOW THE FACILITY REPROCESSES THE DEVICE IN THE BASKET OF AN ETD4 REPROCESSOR. THE CUSTOMER INDICATED THEY HAD NO INSTRUCTIONS FOR MACHINE CLEANING THE STOPCOCK DEVICES. THE CYSTOSCOPES HAD A CLEAR AND PROVEN WASHING PROCESS THAT HAD NOT BEEN CHANGED. IT WAS WHEN THEY CHANGED TO THE NEW STOPCOCK DEVICE THAT THE URINARY TRACT INFECTIONS APPEARED, THEREFORE IT IS THE LIKELY SOURCE OF THE INFECTIONS. THE CUSTOMER INDICATED THEY DID NOT KNOW IF THE STOPCOCKS HAD BE CULTURED. ADDITIONAL INFORMATION REGARDING EACH INDIVIDUAL PATIENT OUTCOME WAS REQUESTED BUT UNKNOWN BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WERE FIVE STOPCOCKS INVOLVED, HOWEVER THEY COULD NOT TRACE WHICH STOPCOCK WAS USED FOR EACH OF THE FOUR INDIVIDUAL PAT

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 20323165 ↗