BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOCLIP

    MDR report key: 2160318 · Received April 27, 2011

    Report

    Report Number
    3003898360-2011-00203
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 4, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD, DEVICE HISTORY RECORD (DHR) REVIEW. COMPLAINT HISTORY REVIEW. RESULTS: DHR REVIEW FOR THE REPORTED LOT NUMBER SHOWED NO SIMILAR ISSUES DURING THE MANUFACTURING OR PACKAGE PROCESS. CONCLUSIONS: DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. ROOT CAUSE UNKNOWN. METHOD OF USE RELATED - DAMAGE DURING USE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN TRYING TO CLIP THE VESSEL THE DISTAL END OF THE CLIP BREAKS THE VESSEL. THE CLIPS WERE USED IN A MICROSURGICAL REPAIR: REVASCULARIZATION OF FLAP. IT IS ALSO REPORTED THAT THE DEVICE WAS USED AND THE ISSUE SOLVED DUE TO THE ABILITY AND EXPERIENCE OF THE SURGEON. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIP LIGATION CLIP FZP TELEFLEX MEDICAL NA 01J1000391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK