BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE

    MDR report key: 20278708 · Received September 23, 2024

    Report

    Report Number
    9610773-2024-02296
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 8, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    UDI-DI
    04042761006927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION RESULTS ARE BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE SERVICE BUSINESS CENTER. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE CAUSE OF THE BROKEN PIN WAS DUE TO IMPROPER HANDLING BY THE CUSTOMER AND APPLICATION OF OUTER FORCE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE EXHIBITED A BROKEN DISTAL END. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487673 GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE SERRATED JAW GRASPER NWW OLYMPUS WINTER & IBE GMBH A4829 237W 04042761006927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown A4773 HYSTEROSCOPE SHEATH