BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER (STANDARD) - 35 MM

    MDR report key: 1831775 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08117
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Report Date
    November 7, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPY PROCEDURE, THE INSTRUMENT DID NOT STAPLE CORRECTLY - INCOMPLETE STAPLE LINE, NO FURTHER INFORMATION IS AVAILABLE. TAKE HF TO STOP THE BLEEDING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER (STANDARD) - 35 MM GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1