BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPTOR GRASPER, SP, ERG TA

    MDR report key: 3013294 · Received March 20, 2013

    Report

    Report Number
    1038548-2013-00006
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K991928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CAREFUSION HAD A CUSTOMER VISIT TO THE FACILITY ON (B)(4) 2013 AFTER NOTIFICATION OF THIS FAILURE AND A SIMILAR FAILURE AT THE FACILITY INVOLVING SP94-8379 DORSEY FENESTRATED GRASPER UNDER COMPLAINT # (B)(4). THE ACTUATION ROD TIP WAS BROKEN OFF FROM THE ROD AS DESCRIBED IN THE COMPLAINT. THE BROKEN ROD PIECE WAS NOT ACCOUNTED FOR. THE CUSTOMER STATED THAT THE PIECE WAS NEVER LOCATED, BUT THAT FOLLOW UP X-RAY OF THE PATIENT WAS NEGATIVE AND THE PIECE WAS NOT BELIEVED TO HAVE BEEN LOST WITHIN THE SURGICAL SITE. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED FAILURE. THE SAMPLE WAS VISUALLY EXAMINED UNDER 10 X MAGNIFICATIONS. MACHINING MARKS WERE EVIDENT (OD OF ROD). THERE WERE SIGNS OF HEAVY LOADING AS THE STEEL WAS DEFORMED AROUND THE 0.034¿ DIAMETER THROUGH-HOLES OF THE ROD TIP. VISUALLY, THE SAMPLE APPEARED TO HAVE FAILED IN THE SAME MANNER. BASIC METROLOGY WAS PERFORMED USING A CALIBRATED CALIPER. THE FOLLOWING DIMENSIONS WERE FOUND WITHIN SPECIFICATION ON THE UNIT: 0.100¿ ROD RADIUS, 0.074¿ TAPERED ROD RADIUS. THE WIDTH OF THE FORKED-TIP OF THE ACTUATION ROD WAS FOUND TO BE UNDERSIZED BY 0.001¿ (0.022¿VS. 0.023 ¿ 0.027¿ LIMITS). NO ROOT CAUSE COULD BE DETERMINED BASED ON THE VISUAL AND DIMENSIONAL ANALYSES PERFORMED. DURING THE CUSTOMER VISIT ON (B)(4) 2013, THE CUSTOMER REQUESTED THE RETURN OF THEIR REMAINING INVENTORY AS A RESULT OF THESE FAILURES. CAREFUSION THEN DID AN INVESTIGATION ON THE REPRESENTATIVE SAMPLES RETURNED BY THE FACILITY. THE CUSTOMER FAILED SAMPLES SHOW A FRACTURE AT THE ROD FORK WHEN PREVIOUS TESTING SHOWS FAILURES OCCURRING EITHER AT THE LINK HOLE OR THE ROD HOLE. IN ANY EVENT THIS INVESTIGATION WAS UNABLE TO REPLICATE THE COMPLAINT FAILURE MODES. AS PART OF THIS INVESTIGATION SAMPLES WERE SENT TO STRESS ENGINEERING SERVICES FOR FURTHER ROD FAILURE ANALYSIS REPORT. THE TESTING RESULTS ON THE CUSTOMER UNITS WERE CONSISTENT WITH PREVIOUS TESTING ¿ IT TOOK OVERSTRESS CONDITIONS (LARGE METAL GAGE PINS, EXTREME MANUAL FORCE, ETC¿) TO GET THE SINGLE ACTION JAW COMPONENTS TO BREAK AT THE LINK OR ROD HOLE. THE COMPLAINT FAILURE MODES COULD NOT BE REPLICATED DURING THIS INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED; THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED OVER THE LAST YEAR FOR THIS INSTRUMENT. THERE HAS BEEN NO OTHER REPORTED COMPLAINT FOR THIS PRODUCT CODE FOR THIS ISSUE. THE CUSTOMER DID FILE ANOTHER SIMILAR COMPLAINT (B)(4) UNDER A DIFFERENT PRODUCT CODE FOR THIS FAILURE MODE. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED FOR EVALUATION, IF DEVICE BECOMES AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WE WERE INFORMED THAT THE TIP OF THE INSTRUMENT BROKE OF INSIDE OF A PATIENT. A CAREFUSION EMPLOYEE DID CALL AND TALK TO THE FACILITY TO WALK THEM THROUGH A PIECE COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116353 RAPTOR GRASPER, SP, ERG TA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION SP94-8365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other