ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 (UDI 04953170310546)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170310546), received between Oct 15, 2020 and Apr 7, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, A DISTAL END LEAK FOR THE ULTRASONIC GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING DIAGNOSTIC (ECHO ENDOSCOPY) AND COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. DEVICE WAS RETURNED AND INSPECTED AND FOUND ACOUSTIC LENS HAD A SCRATCH WHICH REACHED TO THE GLUE-LAYER. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702721 ↗
• MalfunctionMay 4, 2021Connection Problem; Output Problem; Connection Problem; Output Problem

  SCOPE CONNECTION ISSUE WAS REPORTED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772159 ↗
• MalfunctionMay 4, 2021Material Integrity Problem; Material Integrity Problem

  THE USER FACILITY REPORTED TO OLYMPUS THAT THE DISTAL TIP RUBBER NEEDED TO BE REPLACED ON THE ULTRASONIC GASTROVIDEOSCOPE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769359 ↗
• MalfunctionApr 27, 2021No Display/Image; Image Display Error/Artifact; No Display/Image; Image Display Error/Artifact

  IT WAS REPORTED, THE ULTRASONIC GASTROVIDEOSCOPE PRESENTED AN ERROR MESSAGE AND NO IMAGE WHILE IN USE. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733458 ↗
• MalfunctionApr 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE DEVICE WAS RETURNED FOR REPAIR AS A SCRATCH WAS OBSERVED ON THE PINK RUBBER PROBE OF THE DEVICE DURING REPROCESSING. AT THE TIME OF ESTIMATION, IT WAS OBSERVED THAT THERE WAS A DEEP CUT ON THE PINK RUBBER OF THE PROBE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686658 ↗
• MalfunctionMar 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED FOR THIS EVENT, DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE, A LEAK WAS OBSERVED UNDER THE METAL AREA WHERE THE BALLOON ENDS. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392071 ↗
• MalfunctionJan 29, 2021Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  IT IS REPORTED PRIOR TO AN UNSPECIFIED DIAGNOSTIC PROCEDURE USING AN ULTRASONIC GASTROVIDEOSCOPE, THE SCOPE WAS INSPECTED AND FOUND TO HAVE THE SILVER RING THAT CONNECTS TO THE ULTRASOUND MACHINE WAS BENT AND NOT PROPERLY LOCKING TO GIVE AN IMAGE. THIS OCCURRENCE DID NOT CAUSE A DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND DEVICE. NO PATIENT DEMOGRAPHICS ARE AVAILABLE. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11254681 ↗
• MalfunctionJan 20, 2021Leak/Splash; Defective Device; Leak/Splash; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH CHIPPED LENS AND LEAK ON THE TIP OF THE SCOPE WAS OBSERVED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11204832 ↗
• MalfunctionJan 8, 2021Unstable; Unstable

  A USER FACILITY REPORTED THAT THE CORD WAS LOOSE FITTING AT THE LIGHT SOURCE ON A GASTROVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT OR INJURIES REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 11141569 ↗
• MalfunctionJan 4, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT IS REPORTED DURING REPROCESSING OF AN ULTRASONIC GASTROVIDEOSCOPE, DISCOLORATION WAS NOTED. THERE WAS NO PATIENT CONTACT/IMPACT RELATED TP THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 11109340 ↗
• MalfunctionDec 23, 2020Complete Blockage; Complete Blockage

  A USER FACILITY REPORTED A BLOCKED WATER CHANNEL ON A GASTROVIDEOSCOPE. THE EVENT OCCURRED DURING REPROCESSING OF THE DEVICE. NO PATIENT INVOLVEMENT OR INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 11068507 ↗
• MalfunctionDec 18, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA EMAIL ON 29DEC2020. THE ISSUE OCCURRED DURING REPROCESSING. THE DATE THIS EVENT IS NOT AVAILABLE. IT IS NOT KNOWN HOW THE DEFECTS AND DAMAGE OCCURRED. NO INFORMATION WAS PROVIDED REGARDING REPROCESSING METHODS OR STORAGE OF DEVICE. THERE WAS NO VISUAL DEFORMATION NOTED ON THE BENDING SECTION OF THE SCOPE. A LEAK TEST IS PERFORMED AFTER EACH USE OF THE SCOPE. IT IS UNKNOWN IF THE DEVICE GOT STUCK IN A SPECIFIC POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11038984 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A LEAK ON A GASTROVIDEOSCOPE. ONE OF THE CAPS CAME OFF WHEN WASHING THE SCOPE. NO PATIENT INVOLVEMENT OR INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 10971667 ↗
• MalfunctionNov 23, 2020Crack; Crack

  AS REPORTED FOR THIS EVENT, DURING REPROCESSING WHEN THE DEVICE COVER WAS REMOVED FOR THE LEAK TEST, THE CRACK IN THE DISTAL END WAS NOTED. THERE IS NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10885517 ↗
• MalfunctionNov 19, 2020Break; Break

  THE CUSTOMER INFORMED THE SERVICE CENTER THAT DURING REPROCESSING, THE ULTRASONIC GASTRO-VIDEOSCOPE WAS NOTED TO HAVE A BROKEN DISTAL TIP. THERE WAS NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10871316 ↗
• MalfunctionOct 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED BY THE USER FACILITY THAT THE ULTRASONIC GASTRO-VIDEOSCOPE HAD A LEAK. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10743742 ↗
• MalfunctionOct 20, 2020Break; No Display/Image; Material Split, Cut or Torn; Break; No Display/Image; Material Split, Cut or Torn

  DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE THE DEVICE SHOWED NO IMAGE ON THE MONITOR. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED FOR ANY PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10707903 ↗
• MalfunctionOct 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SERVICE CENTER WAS INFORMED THAT THE ULTRASONIC GASTRO-VIDEO SCOPE'S RED PROBE COVER WAS CUT. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10687685 ↗