BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRAU-ALLIS GRASPING FORCEPS, RATCHET, 3.5MM, 32CI

    MDR report key: 751737 · Received August 17, 2006

    Report

    Report Number
    2430952-2006-00033
    Event Type
    Injury
    Date Received
    August 17, 2006
    Report Date
    August 15, 2006
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    GEN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE GRASPER FAILED DURING A LAPAROSCOPIC NISSEN PROCEDURE WITH A BROKEN JAW BEING RETRIEVED FROM THE PT. THE INSTRUMENT BROKE WHILE BEING WITHDRAWN FROM THE TROCAR. THE PIECE WAS RETRIEVED WITHOUT NEED FOR X-RAYS, BUT DISCARDED AND NOT SUBMITTED WITH THE INSTRUMENT. FURTHER INFO HAS BEEN REQUESTED. THE INSTRUMENT IS ESTIMATED TO BE 5-6 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAU-ALLIS GRASPING FORCEPS, RATCHET, 3.5MM, 32CI JARIT ENDOSCOPIC INSTRUMENT GEN KOSCHER & WUERTZ GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention