BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 3779049 · Received April 15, 2014

    Report

    Report Number
    2951238-2014-00181
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    HFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADD'L INFO OR IF THE DEVICE IS REC'D AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY THE DEVICE WOULD NOT COAGULATE. A SECOND DEVICE WAS OPENED AND WOULD ALSO NOT COAGULATE. PATIENT INJURY WAS REPORTED, HOWEVER, THE CUSTOMER WOULD NOT PROVIDE DETAILS AS TO THE EXTENT OF THE INJURY. THE PROCEDURE WAS NOT COMPLETED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO BUT NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230885 PKS CUTTING FORCEPS FORCEPS HFB GYRUS ACMI INC. 920005PK JF820286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PKS CUTTING FORCEPS, 92005PK| REG #(B)(4)