BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER

    MDR report key: 261543 · Received February 7, 2000

    Report

    Report Number
    1527736-2000-00371
    Event Type
    Malfunction
    Date Received
    February 7, 2000
    Report Date
    January 11, 2000
    Manufacturer
    POST SURGICAL MFG
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE EL214 JAWS BECAME LOOSE AND DO NOT HOLD THE CLIP SECURELY. 1/11/2000 MESSAGE FROM AFFILIATE. THE CLIPS FELL INTO THE PT AND WERE RETRIEVED. NO FURTHER COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER CLIP APPLIERS - ENDOSCOPIC GDO POST SURGICAL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other