BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTO-LOK DUAL CUP GRASP FCPS 5

    MDR report key: 5046457 · Received May 11, 2009

    Report

    Report Number
    2430952-2009-00033
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    February 2, 2009
    Report Date
    April 15, 2009
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTS THAT THE INSTRUMENT BROKE DURING USE. ADDITIONAL INFORMATION OBTAINED. THE CUSTOMER REPORTED THAT THE DEVICE BROKE WHEN GRASPING THE APPENDIX WHILE PERFORMING A LAPAROSCOPIC APPENDECTOMY. THE PIECE WAS RETRIEVED WITHOUT DIFFICULTY AND THERE WAS NO HARM TO THE PATIENT OR PROLONGED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTO-LOK DUAL CUP GRASP FCPS 5 N/A GCT KOSCHER & WUERTZ GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR