BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1241099 · Received November 21, 2008

    Report

    Report Number
    3005075853-2008-03280
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/19/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAR PROCEDURE, THE DEVICE WAS DIALED DOWN BUT AFTER FIRING THE RESIDENT WAS UNABLE TO REMOVE THE DEVICE. THE RESIDENT HAD TO PULL THE DEVICE OUT CAUSING DAMAGE TO THE STAPLE LINE. THE PATIENT RECEIVED A TEMPORARY COLOSTOMY, BUT SINCE HAS BEEN REVERSED.

    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