BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK ELECTRODE PARTIALLY INSULATED TIP, 5MM 32CM

    MDR report key: 497542 · Received November 18, 2003

    Report

    Report Number
    2430952-2003-00017
    Event Type
    Malfunction
    Date Received
    November 18, 2003
    Date of Event
    October 21, 2003
    Report Date
    November 18, 2003
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED FOR A GALLSTONE PANCREATITIS LAPAROSCOPIC PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE J HOOK BROKE OFF WHILE IN THE PT. THE TIP THE J HOOK WAS RETRIEVED WITH GRASPER. NO CONSEQUENCES OR IMPACT TO THE PT WAS REPORTED AT THE PRESENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOOK ELECTRODE PARTIALLY INSULATED TIP, 5MM 32CM JARIT ENDOSCOPIC INSTRUMENT GEI TONTARRA MEDIZINTECHNIK GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *