WATER-RESISTANT CAP MAJ-962Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170365478), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ENDOSCOPE POSITION MARKING PROBE AND ITS WATER-RESISTANT CAP HAD THE O-RING FALL OFF THE CAP AND BE REPROCESSED MULTIPLE TIMES. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322463 ↗
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- BALLOON CONTROL UNIT OBCUOlympus Medical Systems Corp. · Enteroscope and accessories16 reports
- ENDOSCOPE POSITION DETECTING UNIT UPD-3Olympus Medical Systems Corp. · Enteroscope and accessories4 reports
- BALLOON CONTROL UNIT OBCUOlympus Medical Systems Corp. · Enteroscope and accessories3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.