BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK L CLIPS

    MDR report key: 3905092 · Received May 27, 2014

    Report

    Report Number
    3003898360-2014-00338
    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

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: AT THE END OF THE PROCEDURE, DURING IRRIGATION, A CLIP FLOATED UP INTO THE SURGEON'S VIEW. HE NOTICED THAT ONE OF THE BOSSES ON THIS CLIP WAS BROKEN. HE HAD NOT NOTICED THAT ANY OF THE CLIPS HE USED DID NOT LOCK. NO PATIENT CONSEQUENCES. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311925 HEMOLOK L CLIPS HEMOSTATIC CLIPPING VESSEL FZP TELEFLEX 01A1400034

    Patients

    Seq Age Sex Outcome Treatment
    1