BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOCLIPS

    MDR report key: 2180836 · Received April 28, 2011

    Report

    Report Number
    3003898360-2011-00208
    Event Type
    Malfunction
    Date Received
    April 28, 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

    EVAL, METHOD: OTHER - DEVICE HISTORY RECORD (DHR) REVIEW. COMPLAINT HISTORY REVIEW. RESULTS: OTHER - DHR REVIEW FOR THE REPORTED LOT NUMBER SHOWED NO SIMILAR ISSUES DURING THE MFG OR PACKAGE PROCESS. CONCLUSIONS: NO EVAL WILL BE PERFORMED. OTHER - ROOT CAUSE UNK. METHOD OF USE RELATED - DAMAGE DURING USE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THIS IS THE EIGHT OUT OF TWENTY ONE COMPLAINTS FROM THE SAME FACILITY. WHEN THEY TRY TO CLIP THE VASCULAR BUNDLE, THE DISTAL END OF THE CLIP BREAKS THE VESSEL. THE CLIPS WERE USED IN A MICROSURGICAL REPAIR: REVASCULARIZATION OF FLAP. IT WAS ALSO REPORTED THAT THE DEVICE WAS USED AND ISSUE SOLVED DUE TO THE ABILITY AND EXPERIENCE OF THE SURGEON. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIPS LIGATION CLIP FZP TELEFLEX MEDICAL 01A1100342

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK