BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE

    MDR report key: 20009888 · Received August 21, 2024

    Report

    Report Number
    9610773-2024-01978
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 8, 2024
    Report Date
    January 10, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    UDI-DI
    04042761006880
    PMA / PMN Number
    510KEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE CAUSE FOR THE BROKEN CONNECTING PIN WAS VERY LIKELY DUE TO INCORRECT REPROCESSING. FURTHERMORE, CORROSION MIGHT WEAKEN THE MATERIAL NEAR THE JAWS, AND IT ALSO INCREASES THE RESISTANCE DURING MOVEMENT. THIS MIGHT CAUSE A BREAKAGE OF PARTS, FOR EXAMPLE OF THE CONNECTION PIN. REGARDING THE CORROSION, THE FOLLOWING REASONS CAN BE POSSIBLE: - AN INAPPROPRIATE CLEANING AGENT IS USED. - THE FORCEPS ARE NOT COMPLETELY DRIED. - MOVING PARTS ARE NOT LUBRICATED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS COULD NOT BE OPENED. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007696 GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS, REUSABLE NWW OLYMPUS WINTER & IBE GMBH A4825 237W 04042761006880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown