BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1160588 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01658
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/11/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE DEVICE WAS DIALED DOWN, AND THE ANVIL POPPED OFF OF THE TROCAR POST AND THEY COULD NOT FIRE THE DEVICE. THE SURGEON HAD TO USE A SECOND LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1