Olympus WA60800CRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Shaft "HiQ+", bipolar, 5 x 330 mm, isolated · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761062398), received between Apr 24, 2023 and Jun 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Integrity Problem1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE SURGICAL SHAFT TIP OF THE FLAT BIPOLAR WAS OBSERVED TO BE BURNT. THE ISSUE WAS OBSERVED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22365638 ↗MalfunctionNov 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THE ELECTRICAL INSULATION FROM THE SUBJECT DEVICE IS DAMAGED AND LEADS TO UNINTENDED THERMAL DAMAGE DURING ACTIVATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE ISSUE OCCURRED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706308 ↗MalfunctionApr 24, 2023Difficult to Remove; Difficult to Remove
A THIRD PARTY DISTRIBUTOR REPORTED TO OLYMPUS, THE BIPOLAR HAND INSTRUMENT (SHAFT "HIQ+", BIPOLAR, 5 X 330 MM, ISOLATED) COULD NOT BE TAKEN APART AFTER THE PROCEDURE . THERE WERE NO USAGE PROBLEMS DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16797281 ↗
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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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