BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHAPORT OBTURATOR AND SEAL SET

    MDR report key: 3181857 · Received June 21, 2013

    Report

    Report Number
    1320894-2013-00061
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 11, 2012
    Report Date
    July 29, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    PMA / PMN Number
    K952977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I RECEIVED FROM THE END-USER FACILITY THE MEDWATCH REPORT NUMBER OF THEIR SUBMISSION REGARDING THIS INCIDENT AFTER MY INITIAL REPORT SUBMISSION. I WANTED TO LINK THE TWO REPORTS TO EACH OTHER. THIS MEDWATCH IS ASSOCIATED WITH THE END-USER MEDWATCH REPORT NUMBER (B)(4) AS REFLECTED IN THE HEADER OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE SEAL OF THE DEVICE (RETAINED DEVICE FRAGMENT) THAT WAS REMOVED FROM THE PATIENT WAS RECEIVED VIA (B)(4) TODAY (B)(4) 2013 AT THE CONMED QUALITY ENGINEERING LAB OF THE COMPLAINT HANDLING CENTER. THE QUALITY ENGINEERING EVALUATION HAS NOT YET COMMENCED, TO DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE QUALITY ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DETACHAPORT OBTURATOR AND SEAL SET ARE SINGLE USE, DISPOSABLE, STERILE SETS INTENDED TO BE UTILIZED WITH THE DETACHAPORT MULTI-USE TITANIUM CANNULAS. THESE DETACHAPORT MULTI-USE TROCARS HAVE APPLICATIONS IN A VARIETY OF PROCEDURES TO PROVIDE A PORT OF ENTRY FOR LAPAROSCOPIC INSTRUMENTATION. THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT POSSIBLE, AS THE LOT NUMBER FOR THIS PRODUCT HAS NOT BEEN MADE AVAILABLE. A FLAPPER CHECK VALVE AND FLAPPER VALVE BUTTON, COMPONENTS OF THE DETACHAPORT KIT 1-7024 WERE RETURNED FOR EVALUATION. THE CHECK VALVE AND VALVE BUTTON WERE SEPARATED AS RECEIVED. THERE WAS A TEAR ALONG THE CENTER HOLE IN THE HINGE OF THE CHECK VALVE. THE VALVE BUTTON WAS DAMAGED, AS IF CUT AND BENT. THE 10/12MM SEAL ASSEMBLY PROCESS FOR DETACHAPORT KIT 1-7024 WAS REVIEWED AT THE PRODUCTION AREA WITH AN OPERATOR AND MANUFACTURING SUPERVISOR. THE VALVE BUTTON IS ASSEMBLED TO THE CHECK VALVE BY USING A TOOL THAT EXPANDS THE CENTER HOLE OF THE VALVE. THE TOOL WAS EXAMINED AND NO SHARP EDGES WERE OBSERVED. SEVERAL VALVE BUTTONS WERE ASSEMBLED IN CHECK VALVES BY THE OPERATOR AND NO ISSUE WITH TEARING WAS EVIDENT, EVEN WHEN ATTEMPTING TO INTENTIONALLY TEAR THE CHECK VALVE. THE FLAPPER CHECK VALVE IS MADE OF A SILICONE MATERIAL WHICH IS VERY RESILIENT WITH CHARACTERISTICALLY HIGH ELASTICITY AND STRENGTH. A 10/12MM DETACHAPORT SEAL/CAP ASSEMBLY WAS MADE BY THE OPERATOR AND A MATING 10MM MULTI-USE THREADED TITANIUM CANNULA WAS OBTAINED FROM THE PRODUCTION AREA FOR EVALUATION. VARIOUS INSTRUMENTS WERE INTRODUCED THROUGH THE SEAL IN AN ATTEMPT TO REPRODUCE THE COMPLAINT FAILURE. THE FAILURE COULD ONLY BE REPRODUCED WHEN THE CHECK VALVE WAS CUT IN THE BUTTON AREA. THEREFORE, IT IS UNLIKELY THE TEAR IN THE MATERIAL WAS CAUSED BY RIGOROUS MANIPULATION ALONE, AND WAS LIKELY CUT. THE SEAL/CAP ASSEMBLY IS THREADED ONTO THE CANNULA AND THE FLAPPER CHECK VALVE IS SUPPORTED BY A LIP INSIDE THE CANNULA. EVEN WITH THE SEAL/CAP ASSEMBLY NOT FULLY SEATED AND THE CHECK VALVE INTENTIONALLY PARTIALLY DETACHED, THE VALVE COULD NOT BE DETACHED USING VARIOUS INSTRUMENTS. IT IS NOTED THAT THE OUTSIDE DIAMETER OF THE VALVE BUTTON IS 0.560 INCH AND THE INSIDE DIAMETER OF A 12MM CANNULA IS 0.502 INCH. THEREFORE, THE VALVE BUTTON WOULD NEED TO BE FORCED THROUGH A 12MM CANNULA AND COULD NOT FALL THROUGH. EVIDENCE SUGGESTS THAT THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THE FLAPPER CHECK VALVE WAS INADVERTENTLY DAMAGED/CUT BY A SURGICAL INSTRUMENT DURING USE, DETACHED, AND WAS PUSHED THROUGH THE TROCAR CANNULA. THE FLAPPER VALVE BUTTON EXHIBITS NUMEROUS SCRAPES, DEFORMITIES AND CUTS SUGGESTING DAMAGE FROM A SHARP INSTRUMENT SUCH AS A SCISSORS. THIS TYPE OF FAILURE IS ADDRESSED IN IFU, INSTRUCTIONS FOR USE, WHICH STATES, "WHEN INSERTING OR REMOVING INSTRUMENTS THAT HAVE SHARP EDGES OR ACUTE ANGLES, CARE MUST BE TAKEN TO AVOID TEARING OF THE SEALS." A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR DETACHAPORT DEVICES FOUND NO COMPLAINTS WHERE THE FLAPPER CHECK VALVE/BUTTON DETACHED DURING USE. THE INCIDENT COULD NOT BE REPRODUCED DURING THE INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THIS COMPLAINT TO BE USE RELATED. ALSO, THIS BEING AN ISOLATED INCIDENT, THERE IS NO TREND FOR THIS TYPE OF FAILURE IN THE DETACHPORT PRODUCT FAMILY. THEREFORE, CORRECTIVE ACTION IS NOT RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    CALL RECEIVED FROM CONMED SENIOR TERRITORY MANAGER (B)(4), STATING HE HAD COMPLETED A COMPLAINT FORM ON (B)(6) 2013 REGARDING SITUATION AT ARROWHEAD. FORM WAS NOT RECEIVED. DETAILS TAKEN OVER THE PHONE. ORIGINAL SURGERY DATE (B)(6) 2012, LAPAROSCOPIC APPENDECTOMY. PATIENT SEEN (B)(6) 2012, COMPLAINED OF PAIN IN LOWER LT QUADRANT, NOT SERIOUS. (B)(6) 2013, PT STILL COMPLAINING OF PAIN, CT SCAN SHOWED SUSPECT FOREIGN BODY. IN (B)(6), PATIENT STILL COMPLAINING OF ABDOMINAL PAIN. (B)(6) 2013, PATIENT RETURNED TO FACILITY FOR SURGERY FOUND "LITTLE WHITE DISK" IN SUBCUTANEOUS TISSUE AREA LEFT LOWER QUADRANT. PORTION OF DEVICE IS RETAINED BY RISK MANAGEMENT, WE WILL CHECK TO SEE IF THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282413 DETACHAPORT OBTURATOR AND SEAL SET OBTURATOR AND SEAL KIT GCJ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention