BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA HOT SERRATED FORCEPS W/O SPIKE

    MDR report key: 9398336 · Received December 2, 2019

    Report

    Report Number
    1037905-2019-00736
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Report Date
    October 30, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KGE
    UDI-DI
    00827002561359
    PMA / PMN Number
    K923470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THAT THE CUPS WERE POTENTIALLY MISALIGNED. DURING A VISUAL EVALUATION, THE CUPS APPEAR TO BE POTENTIALLY MISALIGNED. THE POTENTIAL MISALIGNMENT IS MOST LIKELY DUE TO ONE OF THE CUPS BEING SKEWED TO THE SIDE. THE CUP IS TWISTED OUTWARD AND THERE'S A GAP IN BETWEEN ONE SIDE OF THE TEETH, WHEN THE CUPS ARE CLOSED. THE TEETH MESH TOGETHER ON THE OTHER SIDE, WHEN THE CUPS ARE CLOSED. WHEN THE DEVICE WAS FUNCTION TESTED, THE CUPS FULLY OPEN WHEN THE HANDLE IS MANIPULATED. THERE WAS A YELLOW SUBSTANCE INSIDE THE CUPS. THE DEVICE WAS NOT FUNCTIONALLY TESTED DOWN THE ENDOSCOPE, DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DEVICE WAS SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER PROVIDED THE FOLLOWING: "ONE (1) DEVICE WAS RETURNED IN A ZIP TYPE BAG WITH PROOF OF DECONTAMINATION. THE DEVICE WAS VISUALLY EVALUATED. NO DEFECTS TO THE HANDLE WERE NOTED. TWO BENDS IN THE CATHETER WERE NOTED AT BOTH 60 CM AND 90 CM DISTAL FROM THE HANDLE. ADDITIONALLY, WHEN THE CUPS' ASSEMBLY WAS IN THE CLOSED POSITION, ONE SIDE OF THE CUPS APPEARED SKEWED AND DID NOT MESH WHILE THE OTHER SIDE OF THE CUPS MESHED APPROPRIATELY. THE CUPS WERE MEASURED FOR MISALIGNMENT. THE MEASUREMENT WAS WITHIN SPECIFICATION." THE DEVICE WAS FUNCTIONALLY EVALUATED. DURING TESTING, WITH THE DEVICE HELD IN STRAIGHT, U­ SHAPED, AND THREE (3), EIGHT INCH (8") LOOP COILED POSITIONS, RESPECTIVELY, IT WAS CONFIRMED THAT THE DEVICE DID NOT OPERATE PROPERLY WHEN THE HANDLE WAS MANIPULATED. THE DEVICE OPENED BUT DID NOT CLOSE COMPLETELY AS DESIGNED. THE DEVICE WAS NOT PLACED WITHIN THE CHANNEL OF AN ENDOSCOPE DUE TO THE CONDITION IN WHICH IT WAS RETURNED. THE DEVICE HISTORY RECORDS FOR PACKAGING WORK ORDER (PWO) WERE REVIEWED. PWO CONSISTED OF ONE ASSEMBLY ORDER (AO), MANUFACTURED AUGUST 2019. THE MANUFACTURING RECORDS AND/OR FQC CHECKLIST DID NOT INDICATE RELEVANT DEFECTS." THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE SUPPLIER PROVIDED THE FOLLOWING: THE REPORTED OBSERVATION FROM THE CUSTOMER THAT THE CUPS APPEARED TO BE SKEWED WAS CONFIRMED. BY DEFINITION OF MISALIGNMENT, THE MEASUREMENT OF THE CUPS WAS WITHIN SPECIFICATION AND THEREFORE NOT MISALIGNED. THE ROOT CAUSE FOR THE REPORTED EVENTS IS UNKNOWN. ALL DEVICES RECEIVE 100% INSPECTION PRIOR TO SHIPMENT. PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. UPON PASSING THE DEVICE DOWN THE COLONOSCOPE CHANNEL, THERE WAS DIFFICULTY PASSING IT ALL THE WAY THROUGH. AFTER THE SAMPLE WAS TAKEN, IT WAS EVEN MORE DIFFICULT TO REMOVE FROM THE COLONOSCOPE. [THIS EVENT WAS NOT REPORTABLE]. ON 05-NOV-2019 WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE CUPS WERE MISALIGNED. ON 15-NOV-2019 THE SUPPLIER FOUND THE CUP ALIGNMENT WAS WITHIN SPECIFICATION, HOWEVER THERE WAS A GAP IN THE TEETH WHEN THE CUPS WERE CLOSED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190167 CAPTURA HOT SERRATED FORCEPS W/O SPIKE KGE, FORCEPS, BIOPSY, ELECTRIC KGE COOK ENDOSCOPY G56135 W4255572 00827002561359

    Patients

    Seq Age Sex Outcome Treatment
    1