BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOCK XL CLIPS 6/CART 84/BOX

    MDR report key: 3963698 · Received May 7, 2014

    Report

    Report Number
    3003898360-2014-00294
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TELEFLEX
    Product Code
    MCH
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. A VISUAL OR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR TRENDING RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: DURING A LAPAROSCOPIC APPENDECTOMY, WHILE CLIPPING THE APPENDIX, THE DOCTOR ATTEMPTED TO CLOSE THE CLIP, WHICH WOULD NOT CLOSE. THE CLIP WAS CLOSED BY USING ANOTHER CLIP. NO PT INJURY REPORTED. PT CURRENT CONDITION REPORTED, AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273365 WECK HEMOLOCK XL CLIPS 6/CART 84/BOX LIGATING CLIPS MCH TELEFLEX 01E1300041

    Patients

    Seq Age Sex Outcome Treatment
    1