ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 (UDI 04953170356261)Recalls & reported problems
Olympus Medical Systems Corp. · GF-UE160-AL5 Radial array EUS scope · Class 2
All models of ULTRASONIC GASTROVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus ultrasonic gastrovideoscope is a flexible endoscope with an ultrasound probe at its tip. Its 1,023 reports mostly describe the scope's outer cover splitting, cracking or peeling, and cleaning problems; some say no patient was involved. There are 4 injury reports and no deaths. Reports rose from 79 in the prior 12 months to 564 in the last 12. 1 recall is open, begun in September 2023, because a drying step in the scope's channel was not validated, so some repaired scopes went back with water inside.
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
- 1,045
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,045 adverse event reports that list this exact device (DI 04953170356261), received between Jul 15, 2019 and Sep 30, 2026 — classified as 4 injuries, 1,041 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (573 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0333-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn573
- Peeled/Delaminated80
- Break64
- Crack52
- Microbial Contamination of Device51
- Failure to Clean Adequately50
- No Display/Image44
- Detachment of Device or Device Component39
Patient problems
- No Clinical Signs, Symptoms or Conditions1,019
- No Patient Involvement9
- No Consequences Or Impact To Patient6
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Laceration(s) of Esophagus2
- Aspiration/Inhalation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 1,045 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image; Material Split, Cut or Torn
The customer reported that the Ultrasonic Gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that there was no ultrasound image and there was a cut on the pink probe. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951510 ↗MalfunctionSep 30, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was observed that during the device evaluation, the Ultrasonic Gastrovideoscope had a hole in scope and a cut in the pink rubber. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950657 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937035 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933240 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
The customer reported a piece of water channel button stuck in the connection port during Reprocessing, involving an Olympus Ultrasonic Gastrovideoscope. During the initial evaluation of the device, Foreign object stuck in the suction cylinder and in the suction port. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931822 ↗MalfunctionSep 28, 2026Difficult to Advance
The customer reported old radial ballon stuck on the scope tip involving an Olympus Ultrasonic Gastrovidescope. There was no patient injury reported
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921506 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
The customer reported that the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device, a cut was observed in the pink rubber. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911748 ↗MalfunctionSep 25, 2026Material Puncture/Hole
The customer reported the Ultrasonic Gastrovideoscope there is a hole in the distal end during reprocessing. During the initial evaluation of the device it was observed, C-CAP Chipped noted. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897922 ↗MalfunctionSep 25, 2026Break
The customer reported a damaged crystal involving an Olympus Ultrasonic Gastrovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895807 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component; Material Split, Cut or Torn
The customer reported that the ultrasonic gastrovideoscope had a damaged transducer during sedation for the procedure. During the initial evaluation of the device, missing thixotropic adhesive (KE45) and a cut in the pink probe were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886519 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
The customer reported that the ultrasonic gastrovideoscope had a separate issue. During the initial evaluation of the returned device, cut on the pink rubber was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884239 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
The customer returned the Ultrasound Gastrovideoscope for a separate issue. During the initial evaluation of the returned device, a cut was observed on the pink rubber of the c-cap. In addition, areas of missing or damaged adhesive were observed around the light guide (LG) lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884219 ↗MalfunctionSep 24, 2026Dent in Material; Material Split, Cut or Torn
The customer returned the Ultrasonic Gastrovideoscope to the service center for a separate issue. During the device analysis, the Investigator indicated that a cut on pink rubber and sharp dent on white cap. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882329 ↗MalfunctionSep 22, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861104 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821728 ↗MalfunctionSep 17, 2026Dent in Material; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809794 ↗MalfunctionSep 17, 2026Material Split, Cut or Torn
The customer returned the ultrasound gastrovideoscope for a separate issue. There was no patient involvement. During inspection of the returned device, a cut was found on the pink rubber.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801967 ↗MalfunctionSep 16, 2026Material Split, Cut or Torn
The customer reported that the Ultrasonic Gastrovideoscope had a separate issue. During the initial evaluation of the device, a cut at the pink rubber was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783125 ↗MalfunctionSep 15, 2026Failure to Clean Adequately
The customer reported that the Ultrasonic Gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the objective lens was dirty. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777344 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763081 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
The customer returned the Ultrasonic Gastrovideoscope to the service center for a separate issue. During the initial evaluation of the device, the Investigator indicated that C-CAP Cut Pink Rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751441 ↗MalfunctionSep 10, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715555 ↗MalfunctionSep 9, 2026Dent in Material; Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692082 ↗MalfunctionSep 9, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690256 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677140 ↗
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- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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