ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170062803)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170062803), received between Aug 6, 2020 and Jan 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE PROBE ON THE ULTRASONIC GASTROVIDEOSCOPE WAS REMOVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092685 ↗
• MalfunctionJun 4, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ULTRASONIC GASTROVIDEOSCOPE FORCEPS ELEVATOR WAS NOT WORKING AND THE WIRE FOR THE ELEVATOR WAS LOOSE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459786 ↗
• MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS ULTRASONIC GASTROVIDEOSCOPE HAD AIR/WATER LEAKAGES FROM THE DISTAL END. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE FOUND: THERE WAS A GAP OF ADHESIVE ON THE DISTAL END DUE TO THE ADHESIVE PEELING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192694 ↗
• MalfunctionMay 14, 2022Failure to Clean Adequately; Failure to Clean Adequately

  A USER FACILITY RETURNED THE OLYMPUS, MODEL GF-UC140P-AL5, ULTRASONIC GASTROVIDEOSCOPE TO OLYMPUS FOR REPAIR DUE TO A REPORT OF "DISTAL END LEAK." UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS DETERMINED THAT THE SCOPE WAS INSUFFICIENTLY OR INCORRECTLY REPROCESSED AND THE SCOPE WAS USED FOR NEXT PROCEDURE. THIS REPORT IS SUBMITTED DUE TO THE SCOPE WAS INSUFFICIENTLY OR INCORRECTLY REPROCESSED AND THE SCOPE WAS USED FOR NEXT PROCEDURE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403028 ↗
• MalfunctionAug 11, 2021Microbial 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, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. COAGULASE-NEGATIVE STAPHYLOCOCCI (>100 CFU/ENDOSCOPE). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, WASSENBURG WD440 ADAPTASCOPE, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306277 ↗
• MalfunctionOct 7, 2020Poor Quality Image; Peeled/Delaminated; Poor Quality Image; Peeled/Delaminated

  AS REPORTED FOR THIS EVENT, DURING AN UNKNOWN PROCEDURE THERE WAS BAD ULTRASOUND IMAGE. THERE IS NO REPORTED ADVERSE IMPACT OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10646282 ↗
• MalfunctionOct 7, 2020Break; Fluid/Blood Leak; Peeled/Delaminated; Break; Fluid/Blood Leak; Peeled/Delaminated

  AS REPORTED FOR THIS EVENT, DURING REPROCESSING THE BLACK TIP OF THE INSERTION TUBE OF THE DEVICE IS READY TO FALL OFF. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10645995 ↗
• MalfunctionAug 6, 2020Biofilm coating in Device; Biofilm coating in Device

  THE CUSTOMER REPORTED TO OLYMPUS A SCOPE THAT HAD A POSITIVE CULTURE FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INJURY, PATIENT INFECTION OR DEATH REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376057 ↗