BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1831414 · Received December 20, 2007

    Report

    Report Number
    1527736-2007-08691
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 12, 2007
    Report Date
    December 12, 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
    FL, US
    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 GASTRIC ROUX-EN-Y PROCEDURE THE DEVICE CLIP DID NOT CLOSE COMPLETELY. IT DID NOT SCISSOR. THEY USED A SECOND DEVICE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE REPORTED. DEVICE IS RETURNING.

    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 D4HW82

    Patients

    Seq Age Sex Outcome Treatment
    1