BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 253496 · Received December 9, 1999

    Report

    Report Number
    1527736-1999-06295
    Event Type
    Malfunction
    Date Received
    December 9, 1999
    Date of Event
    November 17, 1999
    Report Date
    November 19, 1999
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN ANTERIOR RESECTION. IT WAS REPORTED BY THE AFFILIATE THAT THE SDH29 WAS USED TO COMPLETE THE COLO-ANAL ANASTOMOSIS IN THE CURRENT MANNER. THE DEVICE WAS FIRED AND REMOVED WITHOUT ANY PROBLEMS; HOWEVER, AN AIR LEAK WAS DISCOVERED WHEN TESTED BEFORE CLOSURE. THERE WAS NO CONSEQUENCE TO THE PT. 12/01/1999 MESSAGE FROM AFFILIATE. THE CASE WAS COMPLETED BY OVERSEWING THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA M4F412

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other