BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK CLIP

    MDR report key: 3905091 · Received May 27, 2014

    Report

    Report Number
    3003898360-2014-00337
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. 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 MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: WHILE ATTEMPTING TO LIGATE A VESSEL, A CLIP DISLODGED FROM THE ROBOTIC APPLIER. NO PATIENT CONSEQUENCES. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311836 HEMOLOK CLIP HEMOSTATIC CLIPPING VESSEL FZP TELEFLEX 01A1400034

    Patients

    Seq Age Sex Outcome Treatment
    1