EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 GF-UCT180Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ultrasound gastroscope (GF-UCT180) uses a probe on its tip to help doctors view the stomach and nearby areas. The 30 reports describe the scope's outer covering and glue coming apart, chipping or splitting, leaving holes in the tip and loose pieces of the probe cover, mostly found during cleaning or servicing. No deaths or injuries were reported, and 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
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170467356), received between Mar 4, 2026 and Sep 30, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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
- Detachment of Device or Device Component32
- Material Split, Cut or Torn8
- Material Puncture/Hole4
- Crack3
- Material Separation3
- Device Reprocessing Problem2
- Gas/Air Leak2
- Loss of or Failure to Bond2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952626 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported that the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device, the probe glue was chipped and no glue at the forceps cover. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944445 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, missing KE-45 (adhesive) on the c-body was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888109 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871415 ↗MalfunctionSep 18, 2026Crack; Gas/Air Leak
The customer reported the ultrasound gastrovideoscope had black water leaking during an unspecified procedure. During the initial evaluation of the device, it was observed the adhesive was cracked off around pink rubber. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822464 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component; Failure to Clean Adequately
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the initial evaluation of the device, missing adhesive at the forceps cover, missing cement around the light guide lens, and a dirty insertion tube was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820456 ↗MalfunctionSep 17, 2026Contamination; Material Separation
The customer reported the Ultrasound Gastrovideoscope had black water coming from scope. During the evaluation of the returned device was missing the adhesive on the light guide and elevator cover was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806254 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797026 ↗MalfunctionSep 15, 2026Crack
The customer reported the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the adhesive was missing at the forceps cover. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778024 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762966 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component; Scratched Material; Material Split, Cut or Torn
The customer reported that the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device, missing thixotropic adhesive (KE-45) on the distal end (C-body) forceps cover, a cut pink rubber and scratches on the light guide lens cement were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717684 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692702 ↗MalfunctionSep 9, 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 on the pink rubber and missing thixotropic adhesive (KE-45) at the light guide cover were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688866 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575292 ↗MalfunctionSep 2, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566562 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565473 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455093 ↗MalfunctionAug 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418103 ↗MalfunctionAug 17, 2026Crack; Material Fragmentation; Detachment of Device or Device Component
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates chips from the pink probe cover, detached adhesive at the forceps cover, and chips on the adhesive on the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287140 ↗MalfunctionAug 17, 2026Material Separation; Detachment of Device or Device Component
The customer reported the Ultrasound Gastrovideoscope had a hole in the distal tip. The event occurred during reprocessing. During the evaluation of the returned device, a chip on the pink transducer was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279485 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis, the investigation indicates there was no adhesive at the forceps cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195088 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165720 ↗MalfunctionJul 28, 2026Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060511 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50033708 ↗MalfunctionJun 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A CUT AT THE PINK PROBE AND MISSING KE-45 (THIXOTROPIC ADHESIVE) AT THE FORCEPS COVER WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667704 ↗
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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.
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