BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4622775 · Received March 23, 2015

    Report

    Report Number
    1219930-2015-00224
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 2, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FTR WAS REASSESSED BASED ON ADDITIONAL INFORMATION RECEIVED AND INVESTIGATORY FINDINGS AND DETERMINED TO BE A NO-REPORTABLE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE IDRIVE ULTRA POWERED HANDLE 1 OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING ANALYSIS, AND AN EVALUATION OF THE RETURNED DEVICE. THE REPORTED CONDITIONS FOR THIS INCIDENT WERE THAT DURING A PANCREAS PROCEDURE THE DEVICE MANIPULATED INSIDE OF THE ABDOMINAL CAVITY AND WAS DIFFICULT TO REMOVE FROM THE TROCAR. ENGINEERING EVALUATED THE RETURNED HANDLE BY LEAK TESTING THE DEVICE. NO LEAKS WERE FOUND ON THE HANDLE GASKET, POTTED NOSE CONE, OR BATTERY COMPARTMENT. THE UNIT WAS THEN DISASSEMBLED AND NO ABNORMALITIES WERE FOUND TO THE INTERNAL COMPONENTS. AN EXCESSIVE MISMATCH WAS NOTED ON THE FRONT HANDLE, EVIDENT BY THE GROOVE IN THE FRONT HANDLE CLOSE TO THE BATTERY COMPARTMENT. HOWEVER, THIS WAS NOT FOUND TO BE A FUNCTIONAL ISSUE. ADDITIONALLY, THE CONFORMAL COATING DID NOT COVER THE ENTIRE BOARD. ENGINEERING THEN POWERED UP THE UNIT AND APPLIED WATER TO THE BLDC BOARD. THE DEVICE DISPLAYED BLUE LIGHTS AND THE FAILURE CODE DRIVE MOTOR STOP QUAD FAIL WAS OBSERVED IN THE EEPROM. THE LEAK PATH IN THE FRONT HANDLE WAS NOT FOUND TO DIRECTLY CONTRIBUTE TO THE REPORTED CONDITION. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE TO THE FLAKING OF THE COATING ON THE CIRCUIT BOARD AND THE REPORTED CONDITIONS WERE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ENGINEERING DETERMINED THAT THE COATING ON THE BLDC BOARD WAS FLAKING, EXPOSING THE CAPACITOR TO FLUID. IF FLUID IS PLACED ON THE CAPACITOR THE DEVICE WILL SHORT OUT RESULTING IN THE QUAD FAILURE. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM REOCCURRING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PANCREAS. ACCORDING TO THE REPORTER: DURING THE FIFTH FIRING, AN ERROR OCCURRED. THE RELOAD ARTICULATED INSIDE THE ABDOMINAL CAVITY. THE PRODUCT WAS REMOVED WITH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. USE OF REINFORCEMENT MATERIAL IS UNKNOWN. THERE WAS NO TISSUE DAMAGE. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO BLEEDING. OPERATING TIME WAS EXTENDED LESS THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194094 IDRIVE ULTRA POWERED HANDLE 1 STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N4G0561ULX

    Patients

    Seq Age Sex Outcome Treatment
    1