BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1020386 · Received February 28, 2008

    Report

    Report Number
    1527736-2008-01249
    Event Type
    Injury
    Date Received
    February 28, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 2/28/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST INSTRUMENT USED AND IT WAS NO PALPABLE RESISTANCE WHILE FIRING NOTICED AND THERE WAS NO FIRING TONE. SURGEON DECIDED TO RECONNECT AND TO USE INSTRUMENT AGAIN, WHEN USED FOR THE SECOND TIME, THE INSTRUMENT CUT BUT DID NOT STAPLE CORRECTLY. THIS LEAD TO A TEMPORARY ARTIFICIAL ANUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM OCW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4GJ5R

    Patients

    Seq Age Sex Outcome Treatment
    1