BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1253008 · Received December 3, 2008

    Report

    Report Number
    3005075853-2008-03414
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 12/03/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THEY HAD THE ANVIL IN THE PROXIMAL END AND THE STAPLER ALL THE WAY IN THE ANUS. THE SURGEON RETRACTED OUT THE TROCAR PART UNTIL HE COULD SEE THE TYING KNOT. HE HEARD IT SNAP TOGETHER. WHILE DIALING IT BACK DOWN IT DE-ENGAGED RIGHT AT THE END OF DIALING IT DOWN. THE TROCAR WAS STUCK BACK IN THE DISTAL TRANS-SECTION, THEREFORE, CAUSING A HOLE IN THE DISTAL TRANS-SECTION. HE COULD NOT OPEN IT BACK UP AND CREATE ANOTHER HOLE SO A COLOSTOMY WAS PERFORMED. THIS IS A TEMPORARY COLOSTOMY. THE PATIENT IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention