BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1832621 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05236
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER. INITIAL ASSESSMENT OF THE HC MACHINE FOUND THAT THE HC FAILED TESTING DUE TO A HEATER BAG TEMPERATURE FAILING PERFORMANCE SPECIFICATIONS - FLUID DELIVERED OUT OF SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT UNDERWENT POSTERIOR LUMBAR DECOMPRESSION AND FUSION WITH PANGEA POLYAXIAL PEDICLE SCREW INSTRUMENTATION FROM L2 TO S1 BILATERALLY, WITH PEDICLE SCREWS AT EACH LEVEL, L2, L3, L4, L5, S1 BILATERALLY. FINAL TORQUE WRENCH MANEUVER PERFORMED. WRENCH REGISTERED PRESCRIBED "CLICK" TO SIGNIFY SYSTEM FINAL TIGHTENING SUCCESSFULLY PERFORMED. MFRS REP PRESENT IN ROOM TO ACKNOWLEDGE. INTRAOPERATIVE AND POSTOPERATIVE DISCHARGE X-RAYS SHOWED INSTRUMENTATION IN GOOD POSITION. PT RETURNED FOR OFFICE FOLLOW UP ON (B)(6) 2010 WITH X-RAYS SHOWING NO ISSUES AND PT ASYMPTOMATIC, DOING WELL. PT RETURNED TO OFFICE FOR FOLLOW UP ON (B)(6) 2010 AND X-RAYS SHOWED ROD TELESCOPED OUT FROM LEFT S1 SCREW, EVEN THOUGH TOP HAT STILL IN PLACE. HEAD OF SCREW WAS ROTATED. NO CHANGE IN OTHER SCREWS NOR IN ROD POSITION IN THESE SCREWS AT L5, L4, L3, NOR L2. NO CHANGE IN POSITION OF IMPLANT ON RIGHT. PT REMAINED ASYMPTOMATIC AND PAIN FREE. PT KEPT ON NO ACTIVE RANGE OF MOTION IN THERAPY. PT RETURNED TO OFFICE FOR FOLLOW UP ON (B)(6) 2010, AND X-RAYS SHOWED HEALING FUSION, AND NO CHANGE IN IMPLANT POSITION FROM FILMS DONE ON (B)(6) 2010. PT REMAINED ASYMPTOMATIC AND PAIN FREE. PT KEPT ON NO ACTIVE RANGE OF MOTION IN THERAPY. HE IS SCHEDULED FOR ANOTHER FOLLOW UP AFTER GOING ON VACATION TO (B)(6), WHEREIN HE HAS BEEN INSTRUCTED TO REFRAIN FROM BENDING AND TWISTING. I THINK THAT THE TORQUE WRENCH TIGHTENED JUST ENOUGH TO HOLD THE COMPONENTS TOGETHER FOR TWO TO THREE MONTHS UNTIL THE CYCLICAL LOADING OF BODY MOTIONS AND FORCES CAUSED THE CONNECTION TO FAIL. NAME: PANGEA FINAL TORQUE WRENCH. STRENGTH: RETURNED TO MFR 9/30/2010 BY HOSPITAL. MFR: SYNTHES USA. NAME: PANGEA SCREW-ROD-TOP HAT CONNECTION MECHANISM. MFR: SYNTHES USA. DIAGNOSIS OR REASON FOR USE: LUMBAR DISC HERNIATION WITH SPONDYLOSIS/SCOLIOSIS; LUMBAR SPINAL STENOSIS WITH SPONDYLOLISTHESIS. SUSPECT DEFECT IS IN THE CALIBRATION OF THE FINAL TORQUE WRENCH OR IN THE SCREW-ROD-TOP HAT CONNECTION THAT FAILS CYCLICALLY OVER TIME WITH BODY MOTION AND FORCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ALL SEVEN TROCARS HAD EXCESSIVE LEAKAGE THROUGHOUT THE PROCEDURE. A SECOND INSUFFLATION MACHINE HAD TO BE BROUGHT INTO THE ROOM AND THE PRESSURE LEVEL WAS SENT HIGHER THAN NORMAL. THE PROCEDURE WAS PROLONGED FOR FIFTEEN MINUTES. THE SAME TROCARS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. SEVEN TROCARS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1