BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FR GRASPER FORCEP

    MDR report key: 15306763 · Received August 26, 2022

    Report

    Report Number
    3003790304-2022-00175
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    August 1, 2022
    Report Date
    October 19, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    HCZ
    PMA / PMN Number
    EXEMPT-HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE ISSUE IS UNKNOWN AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON CUSTOMER RESPONSE TO FOLLOW UP AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. COMMUNICATION WITH THE CUSTOMER, CONVEYED THE FOLLOWING INFORMATION: CUSTOMER STATED THAT THE DEVICE WILL NOT BE RETURNED. ACCORDING TO THE CUSTOMER, WHEN OLYMPUS WAS CONTACTED REGARDING THE ALLIGATOR FORCEPS THAT A PIECE BROKE OFF DURING A PROCEDURE, HE WAS ADVISED THAT THE FORCEPS COULD NOT BE REPAIRED. CUSTOMER STATED THAT THE PIECE THAT BROKE OFF WAS RETRIEVED (PROCEDURE WAS A HYSTEROSCOPY, THE SURGEON VISUALIZED THE FORCEPS BREAK AND WAS ABLE TO RETRIEVE THE PIECE). CUSTOMER DISPOSED THE BROKEN FORCEPS AND THE PIECE WHEN THE NEW FORCEPS ARRIVED. PHYSICAL EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE CUSTOMER IS NOT RETURNING THE SUBJECT DEVICE. A PROBABLE CAUSE IS DIFFICULT TO DETERMINE WITH THE LIMITED AVAILABLE INFORMATION. THE DEVICE HISTORY RECORD (DHR) CANNOT BE COMPLETED AS THE SERIAL NUMBER IS NOT AVAILABLE AND THE DEVICE WAS NOT RETURNED. COMPLAINT HISTORY REVIEW WAS PERFORMED AND FOUND ZERO (NONE) CURRENTLY OPENED OR CLOSED CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) FOR MODEL GYA-5. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HYSTEROSCOPY THE ALLIGATOR FORCEPS HAD BROKE AND WAS RETRIEVED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490612 5FR GRASPER FORCEP GRASPER FORCEP HCZ GYRUS ACMI, INC GYA-5 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown