BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOC PLUS ENDOTOUCH APPLIER 13" CVD

    MDR report key: 2715208 · Received August 22, 2012

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    Report

    Report Number
    1044475-2012-00111
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    July 30, 2012
    Manufacturer
    TELEFLEX
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: INSTRUMENT IS USED IN LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE MOSTLY AND DUE TO VERY FREQUENT USAGE, IT NEEDS TO BE REPAIRED SINCE JAWS DO NOT HOLD CLIP AS FIRMLY AS BEFORE. ISSUE WAS REPORTED AT POST CLEANING/REPROCESSING DURING INSPECTION OF THE DEVICE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOC PLUS ENDOTOUCH APPLIER 13" CVD ENDO APPLIER GDO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1