BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPER, WAVY DOUBLE-ACTION, 36CM

    MDR report key: 7338202 · Received March 14, 2018

    Report

    Report Number
    1923569-2018-00006
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 28, 2018
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K991928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 881471, 881458, 881980, OR 882023. 7TH, 8TH, 27TH, 30TH JUNE 2016. ONE (1) WAVY GRSP DA 5/36 DL2TA RH WAS RETURNED AS THE COMPLAINT SAMPLE. THE LOT CODE WAS ETCHED NORMALLY AND DISPLAYED AS F16 (JUNE) 2016). UPON INITIAL VISUAL INSPECTIONS, THE SAMPLE WAS COMPRISED OF THE RATCHETING HANDLE WITH ROTATION KNOB, THE BLACK INSULATED SHAFT AND THE INSERT. THESE PIECES WERE DISASSEMBLED TO VISUALLY OBSERVE INDIVIDUALLY. OVERALL THE SAMPLE APPEARED SLIGHTLY USED WITH A FEW SCRATCHES ON THE HANDLE. ONE OF THE PINS EXHIBITED SIGNIFICANT WEAR ON THE EDGE AND RUB MARKS WERE SEEN ON THE CORRESPONDING CLEVIS SURFACE. IT SHOULD BE NOTED THAT ASIDE FROM THE NOTED FAILURE MODE NO EXCESSIVE MARKS OR SIGNS OF FORCES WERE NOTED. NO MISSING OR EXTRA PARTS WERE NOTED ON THE RETURNED SAMPLE. FUNCTIONAL INSPECTIONS WERE PERFORMED FOLLOWING INITIAL VISUAL OBSERVATIONS. THE INSERT WAS PLACED INTO THE SHAFT AND ROTATED TO LOCK INTO PLACE. THIS SUBASSEMBLY WAS THEN FIT INTO THE OPEN HANDLE. WHEN ASSEMBLED, THE SAMPLE¿S HANDLE WOULD ACTUATE THE JAW. WHEN THE SAMPLE¿S JAW AND SHAFT WAS ROTATED 90 DEGREES CLOCKWISE, THE SAMPLE WOULD ACTUATE ONCE, BUT AFTER FURTHER MOTIONS OF THE HANDLE THE JAW WOULD ONLY CLOSE SLIGHTLY FROM THE OPEN ORIENTATION, LEAVING THE JAW OPEN. FURTHER OBSERVING THE OBSTRUCTION TO CLOSING, THE PIN IN THE BACK OF THE TOP HALF OF THE JAW WAS PROTRUDING, AND WHEN THE OPERATION OF CLOSING THE SAMPLE WAS ATTEMPTED, THE PIN HIT THE LOCATION AT WHICH THE MARK ON THE CLEVIS WAS OBSERVED. WHEN THE PIN WAS FORCED BACK INTO PLACE THE HANDLE WOULD OPEN AND CLOSE THE JAW ONCE AGAIN. IN ALL ORIENTATIONS THE PIN DID NOT FULLY FALL OUT OF THE JAW ASSEMBLY. UNDER FURTHER MAGNIFICATION IT WAS OBSERVED THAT THE PIN HEAD WAS NOT PEENED ENOUGH TO HOLD THE PIN IN PLACE. BASED ON THE VISUAL AND FUNCTIONAL INSPECTIONS OF THE F16 TAKE APART SAMPLE THE FAILURE MODE OF BROKEN COMPONENT, MORE SPECIFICALLY THE INSERT, WAS VERIFIED. NO DEFECTS WERE OBSERVED ON EITHER THE HANDLE OR THE SHAFT. THIS FAILURE MODE WAS MOST LIKELY CAUSED BY AN OPERATOR ERROR LACK OF PEENING OVER (MUSHROOMING) OF THE PIN CAUSING THE PIN TO NOT MOVE IN THE ASSEMBLY. WITH ADDITIONAL USE AND THE WEAR ON THE CLEVIS THE PIN BECAME MORE SUSCEPTIBLE FOR FAILURE. THE DEVICE HISTORY RECORDS FOR THE SP94-8384, LOT CODE F16 WERE REVIEWED: ALL WORK INSTRUCTIONS WERE COMPLETED ACCORDINGLY. NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. QA TESTING WAS PERFORMED, ALL INSPECTIONS PASSED. THE MOVEMENT OF THE RIVET FROM THE BACKSIDE OF THE JAW MAY HAVE BEEN FACILITATED BY THE LOOSE RIVET PIN THAT WAS NOT PEENED OVER CORRECTLY ON ONE END. BASED ON THE OBSERVATIONS SO FAR, THE MOST PROBABLE CONCLUSION TO THE CAUSE OF FAILURE WAS NARROWED DOWN TO THE JAW AND LINK ASSEMBLY WAS NOT ASSEMBLED CORRECTLY DUE TO THE RIVET PIN NOT PEENED DOWN CORRECTLY. UPON REASSEMBLY THE OVERALL SAMPLE FUNCTIONED NORMALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MY CUSTOMER INFORMED ME THAT THE PIN IS FALLING OUT ON THE JAW OF THIS LAP INSTRUMENT AND THEY WOULD LIKE TO SEND IT IN FOR WARRANTY REPLACEMENT. THE EVENT DATE WAS (B)(6) 2018, QUESTIONS ON GRASPER. THIS PROBLEM DID NOT AFFECT ANY PATIENT, THEY WERE PULLED AND REPLACED. JAWS LOCK IN OPEN POSITION WHEN PIN MOVES. THE ISSUE OCCURRED IN A PROCEDURE, JAWS LOCKED OPEN/ PULLED AND REPLACED, NO PATIENT INJURY OR INTERVENTION, PATIENT WAS STABLE AFTER THE EVENT, NO PART OF THE DEVICE FELL INTO THE PATIENT'S BODY, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL PROCEDURE, THE PROCEDURE WAS COMPLETED AS PLANNED. OTHER QUESTIONS WERE ASKED BUT ANSWERS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183010 GRASPER, WAVY DOUBLE-ACTION, 36CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC F16

    Patients

    Seq Age Sex Outcome Treatment
    1 Other