BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 5961068 · Received September 19, 2016

    Report

    Report Number
    1219930-2016-00997
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 24, 2016
    Report Date
    August 25, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): EGIAADAPT, ENDO GIA ADAPTER STANDARD SERIAL NUMBER (B)(4), INTB100, IDRIVE BATTERY PACK, SERIAL NUMBER (B)(4), EGIA60AMT, EGIA 60 ARTICULATING MED/THICK SULU, LOT # UNKNOWN, K083519.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING PREPARATION PRIOR TO A LAP. LOW ANTERIOR RESECTION SURGERY, THE ADAPTER CONNECTED TO THE HANDLE AND CONFIRMED THE TWO GREEN INDICATOR ILLUMINATED. THEN THE SULU LOADED AND CHECKED THE JAW MOVEMENT WAS OK. SURGEON TRIED USING, BUT COULD NOT USE. THE STATUS INDICATOR ILLUMINATED BLUE. OTHER IDRIVE HANDLE WAS USED. UDI NUMBER IS NOT AVAILABLE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611974 IDRIVE ULTRA POWERED HANDLE 1 STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 C2016B129

    Patients

    Seq Age Sex Outcome Treatment
    1