ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 (UDI 04953170203107)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ULTRASONIC GASTROVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus GF-UE160-AL5 ultrasound gastroscope is a flexible scope used to look at the stomach and surrounding anatomy with sound waves. Its 30 reports mostly describe physical damage found during inspection or evaluation, such as cuts and tears in the pink rubber covering, peeling glue between the acoustic lens and the ultrasound probe, dents, material separating, and fluid or blood leaking inside; most involved no patient at all. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04953170203107), received between Dec 19, 2018 and Apr 23, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Reports received per month
Most reported problems
Device problems
- Break5
- Fluid/Blood Leak5
- Dent in Material4
- Material Puncture/Hole4
- Material Split, Cut or Torn4
- Microbial Contamination of Device2
- Scratched Material2
- Corroded1
Patient problems
- No Patient Involvement14
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED CUT ON COVER (PINK RUBBER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24963416 ↗MalfunctionMar 20, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE DISPLAYED DAMAGED GLUE BETWEEN ACOUSTIC LENS AND ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651922 ↗MalfunctionJan 2, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED THE PINK RUBBER FLOATING (MATERIAL SEPARATION). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943663 ↗MalfunctionDec 23, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED FOREIGN SUBSTANCE WAS FOUND IN THE BRUSH PASSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874587 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED A CUT ON THE PINK RUBBER AND MISSING ADHESIVE AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707510 ↗MalfunctionSep 18, 2025Break; No Display/Image; Break; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED IMAGE ISSUES DUE TO A DAMAGED ULTRASONIC PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088565 ↗MalfunctionJul 16, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED THE CAP WAS NOT ON THE SCOPE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749467 ↗MalfunctionApr 29, 2021Dent in Material; Dent in Material
THE DEVICE WAS SENT IN FOR REPAIR FOR AN ISSUE WITH BALLOONS POPPING DURING A SPY PROCEDURE AT THE LIVER OF A PATIENT, AT WHICH TIME THE ESTIMATION TEAM OBSERVED THE PROBE UNIT OF THE DEVICE TO HAVE SHARP DENTS. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11747273 ↗MalfunctionMar 31, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICE RED COATING IS WEARING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11596345 ↗MalfunctionMar 17, 2021Dent in Material; Dent in Material
DURING A STANDARD SERVICE INSPECTION, THE ASSET ULTRASONIC GASTRO-VIDEOSCOPE WAS FOUND TO HAVE SHARP DENTS ON THE DISTAL TIP OF THE PROBE UNIT. THERE WAS NO ALLEGED PROBLEMS ASSOCIATED WITH THE DEVICE AND THERE WAS NO REPORT OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11509626 ↗MalfunctionMar 17, 2021Material Puncture/Hole; Material Puncture/Hole
AS REPORTED FOR THIS EVENT, THE DEVICE PINK RUBBER OF THE ULTRASOUND PROBE HAD A HOLE. THERE IS NO REPORTED HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11508126 ↗MalfunctionMar 10, 2021Poor Quality Image; Poor Quality Image
THE USER FACILITY REPORTED AN INTERMITTENT IMAGE DISTORTION WHEN USING THE ULTRASONIC GASTROVIDEOSCOPE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11454496 ↗MalfunctionFeb 5, 2021Dent in Material; Dent in Material
DURING A STANDARD SERVICE INSPECTION OF A CUSTOMER RETURNED ASSET, THE ULTRASONIC GASTRO-VIDEOSCOPE WAS FOUND TO HAVE A DAMAGE/SHARP INDENTATIONS ON THE PROBE UNIT. THERE WAS NO REPORT OF ANY PROBLEMS ASSOCIATED WITH THE DEVICE AND THERE WAS NO PATIENT INJURY OR HARM REPORTED TO OLYMPUS.
Patient problems: No Patient Involvement
MAUDE report 11287006 ↗MalfunctionFeb 5, 2021Break; Corroded; Dent in Material; Scratched Material; Break; Corroded; Dent in Material; Scratched Material
IT IS REPORTED AN ULTRASONIC GASTROVIDEOSCOPE FAILED THE LEAK TEST. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11285719 ↗MalfunctionJan 28, 2021Image Display Error/Artifact; Scratched Material; Material Split, Cut or Torn; Physical Resistance/Sticking; Image Display Error/Artifact; Scratched Material; Material Split, Cut or Torn; Physical Resistance/Sticking
UPON MANUFACTURER INSPECTION OF A RETURNED LOANER ULTRASONIC GASTROVIDEOSCOPE, A DEEP CUT IN THE PINK RUBBER WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. NO ISSUES WERE REPORTED BY THE CUSTOMER FACILITY.
Patient problems: No Patient Involvement
MAUDE report 11246083 ↗MalfunctionJan 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT THE SCOPE FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11182584 ↗MalfunctionJan 7, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE SERVICE CENTER WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, THE SCOPE WAS LEAKING AND THE BALLOON WOULD NOT FILL. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11131330 ↗MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE SERVICE CENTER WAS INFORMED THAT DURING REPROCESSING, A TEAR AND A LEAK WERE NOTED ON THE SCOPE¿S BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11126732 ↗MalfunctionDec 18, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING REPROCESSING THE DEVICE WAS OBSERVED TO HAVE A LEAK. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11039503 ↗MalfunctionNov 25, 2020Crack; Crack
IT WAS REPORTED DURING REPROCESSING OF ULTRASONIC GASTROVIDEOSCOPE, AIR/WATER LEAKAGE WAS NOTED AT THE DISTAL TIP. NO PATIENT CONTACT/IMPACT.
Patient problems: No Patient Involvement
MAUDE report 10899645 ↗MalfunctionNov 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE SERVICE CENTER WAS INFORMED THAT DURING REPROCESSING , THE SCOPE FAILED THE LEAK TEST DUE TO A HOLE IN THE DISTAL TIP RUBBER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10857651 ↗MalfunctionNov 5, 2020Break; Break
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE ULTRASONIC TRANSDUCER SURFACE OF THE DEVICE WAS MISSING. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10796730 ↗MalfunctionNov 3, 2020Material Puncture/Hole; Material Puncture/Hole
THE SERVICE CENTER WAS INFORMED THAT A HOLE WAS NOTED IN THE BENDING SECTION RUBBER AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10782000 ↗MalfunctionOct 29, 2020Material Puncture/Hole; Material Puncture/Hole
THE SERVICE CENTER WAS INFORMED THAT THE ULTRASONIC GASTRO-VIDEO SCOPE HAS A HOLE IN IT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10754987 ↗MalfunctionOct 27, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
A USER FACILITY REPORTED DEFECTS IN THE ULTRASOUND PROBE AND A LEAK IN THE ULTRASOUND CORD. THE ISSUE WAS FOUND 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 10742914 ↗
Other Transducer, ultrasonic, diagnostic devices
- Site~Rite 8 Ultrasound System 9770603Bard Access Systems, Inc. · Transducer, ultrasonic, diagnostic620 reports
- ULTRASONIC PROBE UM-S20-17SOlympus Medical Systems Corp. · Transducer, ultrasonic, diagnostic2 deaths344 reports
- Transducer X7-2t 989605414122Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic6 recalls21 reports
- EPIQ Diagnostic Ultrasound System 989605488741Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic3 recalls165 reports
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
- Transducer L12-3 989605412072Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls1 report
- Transducer L15-7io 989605387852Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
- Transducer eL18-4 EMT 989605431531Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page