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Olympus WA69320LRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 430, CroceOlmi, 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 04042761079280), received between Jun 15, 2021 and Feb 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Detachment of Device or Device Component1
  • Fracture1
  • Material Fragmentation1
  • Material Twisted/Bent1
  • Mechanical Problem1

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.

  • InjuryFeb 2, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CYSTECTOMY, APPROXIMATELY 5 MM OF THE LOWER PORTION OF THE TIP OF THIS FORCEPS WAS DAMAGED AND FELL OFF INTO THE ABDOMINAL LUMEN. OTHER FORCEPS WAS USED TO SUCCESSFULLY RETRIEVE THE PART THAT FELL OFF. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24240650 ↗
  • MalfunctionMay 30, 2023Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED TO OLYMPUS, THE TIP OF THE HANDLE IS BENT ON THE JAWS INSERT. THE ISSUE WAS FOUND DURING AN ESOPHAGECTOMY RECONSTRUCTION (UNDER LONGITUDINAL MIRROR) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL NUMBER. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO PROBLEMS WERE OBSERVED. THERE WAS NO DELAY AND NO REPORTS OF PATIENT HARM. THE TIME AND FURTHER DETAILS OF THE EVENT ARE UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17021168 ↗
  • MalfunctionJun 15, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, ONE JAWS DISTAL END BROKE WHEN TAKING AND CLAMPING THE TISSUE AND A FRAGMENT FELL INTO THE PATIENT'S BODY CAVITY. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11997463 ↗

Other Electrosurgical, Cutting & Coagulation & Accessories devices

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Sources and updates

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