BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1396341 · Received May 29, 2009

    Report

    Report Number
    3005075853-2009-03179
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 5, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FHM
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/29/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A SIGMOID RESECTION PROCEDURE, THE SURGEON USED THE FIRST DEVICE, BUT THE STAPLES DID NOT FORM A COMPLETE B SHAPE. THE HAD DIALED THE DEVICE DOWN TO HALF-WAY IN THE WINDOW (1.75MM). AFTER THE FIRST ANASTOMOSIS LEAKED AND HE STARTED COMPLAINING THE SALES REP AND HIM DISCUSSED IT AND THAT IS WHEN IT WAS DISCOVERED THAT HE ASSOCIATED THE BLUE ON OUR DEVICE BOX AS 1.5MM CLOSED STAPLE HEIGHT ON THE EEA. HE WAS EXTREMELY FRUSTRATED BY THIS AND AT HIMSELF, SO HE DECIDED TO CONVERT TO OPEN TO COMPLETE A LOW ANTERIOR RESECTION WITH A CONTOUR DEVICE. WHEN THE SURGEON OPENED THE SECOND DEVICE AND HEARD THE CLICK UPON CONNECTING THE ANVIL, THE ANVIL KEPT FALLING OFF. AT THIS POINT THE SURGEON PULLED AN AUTO SUTURE DEVICE, BUT THEN DECIDED TO JUST HAND SEW THE ANASTOMOSIS CLOSED. THE PATIENT HAD TO HAVE A TEMPORARY ILEOSTOMY. THE ILEOSTOMY WAS NOT IN THE NORMAL LOCATION. THE SURGEON ENDED UP PUTTING IT AT THE TOP OF THE INCISION WHICH HE FEARED COULD CAUSE MORE ISSUES BUT HE DIDN'T THINK HE HAD ANY OTHER OPTION AT THE TIME. THE PROCEDURE STARTED OUT AS AN HOUR AND A HALF LONG CASE, BUT ENDED UP SIX HOURS. THE PATIENT WAS RELEASED A FEW DAYS LATER AND WILL RETURN IN THE NEXT FEW WEEKS TO DETERMINE IF THEY CAN REVERSE THE ILEOSTOMY. THE PRE-OP DIAGNOSIS WAS DIVERTICULUS WITHOUT HEM. THE SURGEON SAID THAT IT WAS YOUR TYPICAL COLON WITH DIVERTICULITIS AND THE TISSUE WAS AS YOU WOULD EXPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM KOG ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - FHM ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R