BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1822316 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08337
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    November 22, 2007
    Report Date
    November 27, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY, THE CLIP JUMPED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO-SURGERY, INC (CINCINNATI) NA D4HM5M

    Patients

    Seq Age Sex Outcome Treatment
    1