Olympus WA69300MRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Shaft "HICURA", 5 x 330, monopolar · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761079112), received between Oct 26, 2022 and Jan 13, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. 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
- Material Integrity Problem1
- Mechanical Problem1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Mechanical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054666 ↗MalfunctionNov 3, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD MECHANICAL DAMAGE AT THE END OF THE COAT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450960 ↗InjuryOct 26, 2022Overheating of Device; Overheating of Device
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC ENDOSCOPIC PROCEDURE AT AN UNKNOWN DATE THE PATIENT SUSTAINED EXTENSIVE BURNS. IT WAS NOTICED THAT THE BASE OF THE SHEATH OF THE FORCEPS IN USE HAD EXPOSED METAL AND WAS SCORCHED. THE INTENDED PROCEDURE WAS CANCELED DUE TO THE BURNS. NO FURTHER INFORMATION WAS PROVIDED. THE HE REPLACED THE FORCEPS WITH ANOTHER FORCEPS AND CONTINUED TO COMPLETE THE PROCEDURE. *THERE ARE NO REPORTS OF TREATMENT OF BURNS BY INTERRUPTING THE PROCEDURE. SHEATH MODEL NUMBER UNKNOWN. ISSUE AS A60800A. (B)(6) 2022 TATSUMI (EMAIL FROM MR. (B)(6)). THE DEFECTIVE PRODUCT IS WA69300M (LOT NUMBER UNKNOWN). SURGERY WAS CANCELED DUE TO BURNS.
Patient problems: Burn(s)
MAUDE report 15672767 ↗
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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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