BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 3193109 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03319
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: NO ON RADIATION. 6TH OR 7TH FIRING EVENT OCCURRENCE. BOWEL ANASTAMOSIS. MALFUNCTION WAS VISIBLE. BLUE CARTRIDGE. NO BUTTRESSING. NO ON STAPLE LINE OR CLIP. DID NOT SOUND RIGHT. NO ON HIGHER FORCE. YES, DIFFICULT REMOVING. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC BYPASS PROCEDURE, THE DOCTOR FIRED THE STAPLER, STAPLES MALFORMED AND DEVICE DID NOT CUT. DOCTOR HAND SEWED ANASTOMOSES. THERE WERE NO PATIENT CONSEQUENCES. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293474 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1