Olympus A37026ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761023221), received between Mar 6, 2020 and Jun 19, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Poor Quality Image” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 19, 2020Poor Quality Image; Poor Quality Image

  THE USER FACILITY REPORTED TO OLYMPUS THAT THERE ARE BLURRY OR FOGGY IMAGE PROBLEMS WITH THE DEVICE. THE IMAGE WAS CLOUDY. THE CUSTOMER SENT THE SCOPE IN FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10176797 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT A PATIENT CONTRACTED A PSEUDOMONAS INFECTION AFTER UNDERGOING AN UNSPECIFIED PROCEDURE WITH THE CYSTOSCOPE. THE USER FACILITY REPORTED THAT THERE WAS BLOOD IN THE PATIENT¿S URINE. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. THIS IS REPORT 1 OF 2.

  Patient problems: Bacterial Infection

  MAUDE report 9801674 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT A PATIENT CONTRACTED A PSEUDOMONAS INFECTION AFTER UNDERGOING AN UNSPECIFIED PROCEDURE WITH THE CYSTOSCOPE. THE USER FACILITY REPORTED THAT THERE WAS BLOOD IN THE PATIENT¿S URINE. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. THIS IS 1 OF 2 REPORTS.

  Patient problems: Bacterial Infection

  MAUDE report 9801554 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT A PATIENT CONTRACTED A PSEUDOMONAS INFECTION AFTER UNDERGOING AN UNSPECIFIED PROCEDURE WITH THE CYSTOSCOPE. THE USER FACILITY REPORTED THAT THERE WAS BLOOD IN THE PATIENT¿S URINE. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. AS PART OF OUR INVESTIGATION , THE SERVICE CENTER FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE SOURCE OF THE INFECTION HAS NOT BEEN DETERMINED AS AN INVESTIGATION IS ONGOING. IN ADDITION, AN ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED ON (B)(4) 2020, TO OBSERVE THE USER FACILITY¿S REPROCESSING METHODS AND PROVIDE AN IN-SERVICE . THE ESS REPORTED THAT THERE WERE NO REPROCESSING DEVIATIONS NOTED WITH THE FACILITY¿S REPROCESSING PRACTICES. HOWEVER, AN IN-SERVICE WAS PROVIDED THAT INCLUDED REPROCESSING TRAINING, BRUSHING, FLUSHING AND STERILIZATION. THE SCOPE WAS RETURNED TO THE SERVICE CENTER AND IS PENDING PHYSICAL EVALUATION AND MICROBIAL TESTING. THE SCOPE WILL BE SENT TO AN INDEPENDENT LABORATORY FOR MICROBIAL TESTING. THIS IS 2 OF 2 REPORTS.

  Patient problems: Bacterial Infection

  MAUDE report 9801497 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT A PATIENT CONTRACTED A PSEUDOMONAS INFECTION AFTER UNDERGOING AN UNSPECIFIED PROCEDURE WITH THE CYSTOSCOPE. THE USER FACILITY REPORTED THAT THERE WAS BLOOD IN THE PATIENT¿S URINE. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. AS PART OF OUR INVESTIGATION , THE SERVICE CENTER FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE SOURCE OF THE INFECTION HAS NOT BEEN DETERMINED AS AN INVESTIGATION IS ONGOING. IN ADDITION, AN ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED ON (B)(6) 2020, TO OBSERVE THE USER FACILITY¿S REPROCESSING METHODS AND PROVIDE AN IN-SERVICE . THE ESS REPORTED THAT THERE WERE NO REPROCESSING DEVIATIONS NOTED WITH THE FACILITY¿S REPROCESSING PRACTICES. HOWEVER, AN IN-SERVICE WAS PROVIDED THAT INCLUDED REPROCESSING TRAINING, BRUSHING, FLUSHING AND STERILIZATION. THE SCOPE WAS RETURNED TO THE SERVICE CENTER AND IS PENDING PHYSICAL EVALUATION AND MICROBIAL TESTING. THE SCOPE WILL BE SENT TO AN INDEPENDENT LABORATORY FOR MICROBIAL TESTING. THIS IS 2 OF 2 REPORTS

  Patient problems: Bacterial Infection

  MAUDE report 9801453 ↗