ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170355431)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170355431), received between Sep 26, 2018 and Dec 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2020Fracture; Fracture

  THE DEVICE WAS RETURNED TO OLYMPUS FOR REPAIR. DURING EVALUATION, THE REPAIR CENTER IDENTIFIED SCRATCHES AND BROKEN BRAIDS ON THE ENDOSCOPIC PROBE. THERE WAS NO PATIENT INVOLVEMENT; THE REPORTABLE MALFUNCTION WAS FOUND DURING SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10963794 ↗
• MalfunctionOct 7, 2020Break; Break

  A USER FACILITY REPORTED BREAKAGE OF THE BLACK TIP OF THE VALVE DURING REPROCESSING OF THE GASTROVIDEOSCOPE. NO PATIENT INVOLVEMENT OF INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 10643952 ↗
• MalfunctionAug 7, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES (>256 CFU / 100ML) . THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, WASSENBURG, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868559 ↗
• MalfunctionSep 26, 2018Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR ENTEROBACTERIA (5CFU/100ML). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE 3, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909210 ↗