BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORCEPS, 5MM/33CM

    MDR report key: 4173527 · Received October 10, 2014

    Report

    Report Number
    2951238-2014-00457
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTING FORCEPS REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF NEW AND SIGNIFICANT INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE TIP OF THE CUTTING FORCEPS BROKE OFF DUE TO EXCESSIVE REGRESS. THE USER REPLACED THE CUTTING FORCEPS WITH ANOTHER SIMILAR DEVICE, BUT THE TIP BROKE OFF AGAIN DUE TO EXCESSIVE REGRESS AS WELL. AS A RESULT, THE USER COMPLETED THE PROCEDURE WITH A NON-OLYMPUS DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING IN AN ATTEMPT TO OBTAIN MORE DETAILED INFORMATION, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642852 PKS CUTTING FORCEPS, 5MM/33CM CUTTING FORCEPS GEI GYRUS ACMI INC. 920005PK JF806544

    Patients

    Seq Age Sex Outcome Treatment
    1 920005PK WITH LOT# JF841160 (2951238-2014-00456)