ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 (UDI 04953170355349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170355349), received between Aug 6, 2020 and Nov 12, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED DURING REPROCESSING THE SUBJECT DEVICE HAD A BLOCKED WATER CHANNEL. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669869 ↗
• MalfunctionSep 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE DEVICE WAS SENT IN FOR REPAIR OF A HOLE IN THE DISTAL TIP OBSERVED DURING AN UNKNOWN PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. DURING INSPECTION FOR REPAIR, IT WAS NOTED THAT THE PINK RUBBER OF THE PROBE UNIT WAS CUT. THIS WAS AFFECTING THE ULTRASOUND IMAGE. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF THE CUT ON THE PINK RUBBER OF THE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508369 ↗
• MalfunctionJul 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE DUE TO A PUNCTURE HOLE IN THE INSERTION TUBE. ONCE RETURNED, EVALUATORS NOTED THAT THE PROBE UNIT HAD BEEN CUT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DAMAGED PROBE UNIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ORIGINAL EVENT OCCURRED DURING REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171661 ↗
• MalfunctionJun 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE BECAUSE THE BALLOON WOULD NOT INFLATE. HOWEVER, UPON FURTHER REVIEW ONCE RETURNED, EVALUATORS DISCOVERED THAT THE PINK RUBBER WAS CUT AND EXPOSING WHITE CERAMIC. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE CUT PINK RUBBER AND EXPOSED CERAMIC. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033680 ↗
• MalfunctionApr 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SERVICE CENTER WAS INFORMED THAT THERE PHYSICAL DEFECTS NOTED ON THE SCOPE¿S BENDING SECTION AND INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737153 ↗
• MalfunctionFeb 16, 2021Break; Break

  A CUSTOMER REPORTED THAT THE ULTRASOUND PROBE UNIT OF THE DEVICE WAS DEEPLY CRACKED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11330921 ↗
• MalfunctionDec 22, 2020Break; Break

  THE SERVICE CENTER WAS INFORMED THAT THE ULTRASONIC GASTRO-VIDEOSCOPE'S CABLES WERE LOOSE OR BROKEN. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11055305 ↗
• MalfunctionDec 11, 2020Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS REPORTED THAT DURING RECEIPT INSPECTION THE DEVICE WAS FOUND, SUSPECTED WITH A DAMAGED TRANSDUCER. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10991350 ↗
• MalfunctionNov 23, 2020Inflation Problem; Inflation Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE BALLOON WAS NOT INFLATING. THE PROBLEM, AS REPORTED TO OLYMPUS, OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886067 ↗
• MalfunctionAug 31, 2020Inflation Problem; Inflation Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING A DIAGNOSTIC PROCEDURE, THE ULTRASOUND GASTROVIDEOSCOPE WAS HAVING BALLOON MALFUNCTIONS AS THE BALLOON WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473318 ↗
• MalfunctionAug 6, 2020Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A REPAIR REDUCTION OBSERVATION IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, THE ENDOSCOPY SUPPORT SPECIALIST (ESS) NOTED SCOPE TECHNICIANS INCORRECTLY PERFORMING THE ASPIRATION STEPS DURING MANUAL CLEANING AS THERE WAS CONFUSION REGARDING THE STEPS. THE ESS OBSERVED A SCOPE TECHNICIAN PERFORM THE REPROCESSING STEPS FOR A GF-UE160-AL5. THE SCOPE TECHNICIAN PERFORMED THE ASPIRATION STEPS INCORRECTLY BY NOT USING THE SUCTION VALVE TO PERFORM ASPIRATION THROUGH BOTH THE SUCTION AND BALLOON CHANNELS.

  Patient problems: No Patient Involvement

  MAUDE report 10373076 ↗