BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIG

    MDR report key: 961430 · Received December 10, 2007

    Report

    Report Number
    1527736-2007-08383
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Report Date
    November 19, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT B: BATCH# D9E34X, EXPIRATION DATE: 7/28/2012; MFR DATE: 8/28/2007. INSTRUMENT C: BATCH# D9E561, EXPIRATION DATE: 8/13/2012; MFR DATE: 9/2007; (JAWS MISALIGNED). INSTRUMENT D: BATCH# D9E561, EXPIRATION DATE: 8/13/2012; MFR DATE: 9/2007. INSTRUMENT E: BATCH D9E621, EXPIRATION DATE: 8/19/2012; MFR DATE: 9/19/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DEVICE WAS FIRED THE CLIPS WERE COMING OUT TWISTED. THEY GOT A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIG FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4J279

    Patients

    Seq Age Sex Outcome Treatment
    1