BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK CLIPS, LARGE

    MDR report key: 2062447 · Received March 18, 2011

    Report

    Report Number
    3003898360-2011-00100
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CLIP CANNOT CLAMP AFTER INSERTED INTO THE PATIENT DURING LAPAROSCOPIC CHOLECYSTECTOMY OPERATION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK CLIPS, LARGE HEM-O-LOK CLIPS FZP TELEFLEX MEDICAL NA 01F1000184

    Patients

    Seq Age Sex Outcome Treatment
    1