BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT SPECIMEN BAG, 10MM

    MDR report key: 2655308 · Received July 13, 2012

    Report

    Report Number
    1320894-2012-00048
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Date of Event
    June 28, 2012
    Report Date
    August 14, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    PMA / PMN Number
    K941500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN TO CONMED CORPORATION IS ANTICIPATED; HOWEVER, HAS NOT BEEN RECEIVED TO DATE. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE NOT YET RECEIVED FROM END-USER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS A DISPOSABLE, SINGLE-USE DEVICE DESIGNED FOR USE DURING MINIMALLY INVASIVE SURGICAL PROCEDURES TO ISOLATE AND RETRIEVE TISSUE, ORGANS, OR STONES. IT IS INTRODUCED INTO THE SURGICAL FIELD THROUGH AN APPROPRIATELY SIZED CANNULA PORT. CHANNELS IN THE DEVICE ARE INFLATED TO OPEN THE MOUTH OF THE BAG AND FORM A RIGID SUPPORT STRUCTURE. ONCE THE SPECIMEN HAS BEEN INSERTED IN THE BAG, IT CAN BE SEALED CLOSED USING A DRAWSTRING MECHANISM, THUS REDUCING THE RISK OF CROSS-CONTAMINATION AND INFECTION. ONCE SEALED, THE SPECIMEN BAG CAN BE SAFELY REMOVED FROM THE SURGICAL FIELD. DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW SHOWED THAT THIS LOT WAS CONFIRMED BY MANUFACTURING DOCUMENTATION TO HAVE BEEN PRODUCED ACCORDING TO MANUFACTURING SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. THE ORIGINAL DEVICE USED IN THE SURGERY WAS NOT AVAILABLE FOR EVALUATION. THE SPECIFIC FAILURE MODE AND ASSOCIATED ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE. THEREFORE, THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. ONE (1) SB31110 DEVICE IN THE ORIGINAL SEALED PACKAGE WITH LOT # 1203121 WAS RETURNED FOR EVALUATION FROM CUSTOMER STOCK AND REVIEWED WITH THE MANUFACTURING ENGINEER FOR THIS PRODUCT. THE SPECIMEN BAG WAS ABLE TO BE DEPLOYED FROM THE CANNULA PROPERLY. VISUAL EXAMINATION OF THE BAG WELDS DID NOT IDENTIFY ANY EVIDENT DEFECTS. THE BAG WAS INFLATED PROPERLY WITH 20CC OF AIR USING A LUER LOCK SYRINGE WITH NO AIR LEAKS. THE BAG WAS THEN PROPERLY CLOSED USING THE DRAWSTRING. THE BAG WAS ABLE TO BE DETACHED BY PULLING BACK ON THE WHITE HANDLE AS PER DFU, DIRECTIONS FOR USE; THEREFORE, THE REPORTED FAILURE WAS NOT ABLE TO BE REPRODUCED WITH THE CUSTOMER STOCK DEVICE. THE CAUSE OF THIS COMPLAINT IS UNDETERMINED. POTENTIAL FAILURE MODES ARE OVERINFLATION OF THE SPECIMEN BAG WHICH CAUSED THE BAG TO RIP AND THE SPECIMEN BAG WAS INADVERTENTLY DETACHED DURING USE BY FORCEFULLY PULLING THE DRAWSTRING OR HANDLE THROUGH THE CANNULA. OVERINFLATION OF THE DEVICE IS MITIGATED IN THE DFU, WHICH STATES, "DO NOT USE MORE THAN 20 CC AIR TO INFLATE THE SB31110 BAG ..." THE SPECIMEN BAG IS DESIGNED TO BE ABLE TO BE DETACHED. THE DFU ALSO STATES, "IF THE SPECIMEN BAG IS TOO LARGE TO WITHDRAW THROUGH THE PORT, REMOVE THE CANNULA AND THE BAG AS A UNIT FROM THE ENTRY SITE. EXTERNALIZE THE MOUTH OF THE BAG. CUT THE BAG OPEN AND GRASP THE EDGES WITH A HEMOSTAT OR TOWEL CLAMP. RETRIEVE THE TISSUE SPECIMEN, ORGAN OR STONES FROM THE BAG UNTIL THE BAG IS ABLE TO BE WITHDRAWN FROM THE INCISION." POTENTIAL CAUSES OF THIS TYPE OF FAILURE ARE MITIGATED BY FUNCTIONAL TESTING IN PRODUCTION. THE SPECIMEN BAGS ARE INFLATED WITH 20 CC OF AIR AND ALLOWED TO SIT FOR 30 MINUTES TO TEST FOR LEAKS IN THE BAG WELDS. THE COMPLAINT INVESTIGATION WAS UNABLE TO REPRODUCE THE REPORTED INCIDENT WITH THE RETURNED LOT SAMPLE DEVICE. THEREFORE CORRECTIVE ACTION IS NOT WARRANTED AT THE PRESENT TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE DISCARDED - LOT SAMPLE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DEVICE WAS BEING USED IN SURGERY AND BAG BROKE AND THE SPECIMEN THAT WAS INSIDE SPILLED BEFORE IT WAS RETRIEVED FROM THE ABDOMEN. SURGERY WAS FINISHED; WHEN THEY WERE LOOKING FOR SPECIMEN THEY REALIZED BAG HAD BROKE, SO THEY HAD TO OPEN PATIENT BACK UP TO RETRIEVE SPECIMENS - THIS JUST HAPPENED EARLY THIS MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACT SPECIMEN BAG, 10MM SPECIMEN BAG GCJ CONMED CORPORATION 1203121

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other