BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3893416 · Received February 11, 2014

    Report

    Report Number
    1219930-2014-00101
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 20, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BARIATRIC PROCEDURE. ACCORDING TO THE REPORTER: CHIEF OF BARIATRIC USES OUR ENDO GIA ROUTINELY WITH SEAMGUARD. FIRED FIRST BLACK 60 LOAD W/SEAMGUARD WORKED. SECOND ONLY WOULD FIRE 20MM, TOOK FINGER OFF WAITED REAPPLIED FINGER WOULD NOT MOVE. LOADED AGAIN WOULD NOT ADVANCE-, FOURTH TRY USED 45 BLACK NO SEAMGUARD WOULD NOT ADVANCE. FINISHED WITH ETHICON ECHELON POWER HAD GOOD STAPLE FORMATION WITH THAT PRODUCT. CURRENT PATIENT STATUS: DISCHARGED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THE DELAY DID NOT AFFECT PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91258 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3G1162UX

    Patients

    Seq Age Sex Outcome Treatment
    1