BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPROXIMATE ILS INTARLUMINAL STAPLER

    MDR report key: 59752 · Received December 23, 1996

    Report

    Report Number
    1628808-1996-00309
    Event Type
    Malfunction
    Date Received
    December 23, 1996
    Date of Event
    November 22, 1996
    Report Date
    December 23, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LOW ANTERIOR RESECTION, IT WAS REPORTED THE AX55G WAS FIRED OVER THE BOWEL AND THE SURGEON CUT THE TISSUE. WHEN THE INSTRUMENT WAS REMOVED, NO STAPLES WERE PRESENT. THE SURGEON MADE PURSE STRING ON THE DISTAL AND PROXIMAL END OF THE BOWEL AND USED A CDH TO COMPLETE THE ANASTOMOSIS. THERE WERE NOT 2 COMPLETE DONUTS, SO THE SURGEON HAND SEWED THE ANASTOMOSIS. THE PT IS STILL NPO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PPROXIMATE ILS INTARLUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other