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Olympus WA63320CRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761063050), received between Jan 10, 2019 and Jan 11, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Excessive Heating” (2 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 16, 2026.

Most reported problems

Device problems

  • Excessive Heating2

Patient problems

  • Burn, Thermal2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 11, 2019Excessive Heating; Excessive Heating

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE GRASPING FORCEPS WERE TRANSMITTING THERMIC ENERGY RESULTING IN INVOLUNTARY BURNING AND COAGULATION OF ADJACENT TISSUES. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED.

    Patient problems: Burn, Thermal

    MAUDE report 8242576 ↗
  • InjuryJan 10, 2019Excessive Heating; Excessive Heating

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE GRASPING FORCEPS WERE TRANSMITTING THERMIC ENERGY RESULTING IN INVOLUNTARY BURNING AND COAGULATION OF ADJACENT TISSUES. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THIS IS 2 OF 3 REPORTS.

    Patient problems: Burn, Thermal

    MAUDE report 8234383 ↗

Other Electrosurgical, Cutting & Coagulation & Accessories devices

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Sources and updates

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