BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP SINGLE CLIP APPLIER

    MDR report key: 320233 · Received March 9, 2001

    Report

    Report Number
    1527736-2001-01163
    Event Type
    Malfunction
    Date Received
    March 9, 2001
    Report Date
    February 9, 2001
    Manufacturer
    POST SURGICAL MFG
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (4) DEVICES WERE USED DURING A CORONARY ARTERY BYPASS GRAFT. IT WAS REPORTED BY THE AFFILIATE THAT THE SMALL CLIP APPLIERS (LX107 AND LX207) SCISSORED THE CLIP IN THE INSTRUMENT JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10530 LIGACLIP SINGLE CLIP APPLIER CLIP APPLIERS - CONVENTIONAL/REUSAB FZP POST SURGICAL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other