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Olympus WA63120CRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761063067), received between May 2, 2018 and Jan 10, 2019 — classified as 3 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 18, 2026.

Most reported problems

Device problems

  • Excessive Heating2
  • Failure to Deliver Energy1
  • Therapeutic or Diagnostic Output Failure1

Patient problems

  • Burn, Thermal2
  • Blood Loss1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • 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 1 OF 3 REPORTS.

    Patient problems: Burn, Thermal

    MAUDE report 8234407 ↗
  • 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 3 OF 3 REPORTS.

    Patient problems: Burn, Thermal

    MAUDE report 8234363 ↗
  • InjuryMay 2, 2018Failure to Deliver Energy; Therapeutic or Diagnostic Output Failure; Failure to Deliver Energy; Therapeutic or Diagnostic Output Failure

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED GYNECOLOGICAL HYSTERECTOMY PROCEDURE AT AN UNKNOWN DATE, THE SUSPECT MEDICAL DEVICE WAS NOT PERFORMING AS EXPECTED SINCE IT WAS NOT COAGULATING PROPERLY AND THE PATIENT SUFFERED FROM POST-OPERATIVE BLEEDING FROM UTERINE VESSELS. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blood Loss

    MAUDE report 7479420 ↗

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Sources and updates

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