BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE INTRALUMINAL CIRCULAR STAPLER - 21MM

    MDR report key: 463803 · Received June 4, 2003

    Report

    Report Number
    1527736-2003-00937
    Event Type
    Injury
    Date Received
    June 4, 2003
    Date of Event
    May 10, 2003
    Report Date
    May 15, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A LAPAROSCOPIC GASTRIC BYPASS. THE SURGERY WAS IN 05/2003. IN 2003 THE PATIENT WAS BROUGHT BACK TO SURGERY FOR A SUSPECTED LEAKY ANASTOMOSIS. THE PHYSICIAN DID AN OPEN EXPLORATORY LAPAROTOMY TO FIND ABSCESS IN ABDOMEN AND THE POSTERIOR PORTION OF STAPLE LINE HAD DEHISED AT THE GASTROJEJUNOSTOMY SITE. PATIENT HAD 300CC OF FLUID REMOVED FROM ABDOMEN, 50% OF THE ANASTOMOSIS HAD FAILED. PATIENT PLACED ON A VENTILATOR IN ICU. DEVICE WAS DISCARDED AS THERE WAS NO BELIEVED MALFUNCTION DURING THE INITIAL SURGERY OTHER THAN MINOR DIFFICULTY REMOVING THE DEVICE. SURGEON IS UNSURE IF THE EVENT WAS DEVICE OR USER RELATED, AS THERE WERE TOO MANY VARIABLES PRESENT TO MAKE A DETERMINATION. AS OF 05/2003 THE PATIENT IS NOT WORSE, BUT NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE INTRALUMINAL CIRCULAR STAPLER - 21MM PROXIMATE ILS CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention