BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    MDR report key: 6525574 · Received April 27, 2017

    Report

    Report Number
    1037905-2017-00220
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    January 4, 2017
    Report Date
    April 28, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    UDI-DI
    00827002560765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. DURING A VISUAL INSPECTION, THE DEVICE WAS RETURNED CUT IN TWO (2) PIECES; AT 13.6 CM DISTAL TO CUPS. NO PORTION OF THE DEVICE WAS MISSING. THE DRIVE WIRE WAS BROKEN AND A PORTION WAS CUT WITH THE OTHER END APPEARING TO HAVE THE SOLDER BROKEN. THE DEVICE COULD NOT BE FUNCTION TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE WILL BE SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER PROVIDED THE FOLLOWING EVALUATION: ONE DEVICE FROM THE REPORTED EVENT WAS RETURNED IN A ZIP TYPE BAG WITH PROOF OF DECONTAMINATION. THE DEVICE WAS DISASSEMBLED . THE PORTION OF THE CONTROL WIRE FOUND IN THE BAG HAS THE APPEARANCE OF A BROKEN SOLDER JOINT AT THE DISTAL TIP. THIS HOWEVER CANNOT BE CONFIRMED WITHOUT THE LINK WIRE PORTION. THE HOUSING OF THE FORCEPS WERE NOT PRESENT DURING THE EVALUATION, ONLY HALF A FORK WITH THE UPPER PORTION WAS RETURNED [NOTE: NO SECTION OF THE DEVICE WAS MISSING DURING THE INITIAL EVALUATION PERFORMED AT (B)(4)]. THE DEVICE HISTORY RECORDS FOR PACKAGING WORK ORDER (PWO) WAS REVIEWED. THE PWO CONSISTED OF TWO ASSEMBLY ORDERS (AO). THESE AOS WERE MANUFACTURED IN NOVEMBER 2016. THERE WERE NO DEVICES REJECTED DURING MANUFACTURING OR FINAL QUALITY CONTROL (FQC). NO OTHER RELEVANT DEFECTS WERE NOTED IN THE RECORDS. 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 CUSTOMER EXPERIENCED ISSUE OF "DIFFICULTY OPENING" WAS CONFIRMED; HOWEVER THE DEVICE WAS DISASSEMBLED UPON RECEIPT. THE ROOT CAUSE CANNOT BE CONFIRMED WITHOUT THE LINK WIRE PORTION. DURING COOK'S EVALUATION OF THE DEVICE NO PORTION OF THE DEVICE APPEARED TO BE MISSING. CLARIFICATON WAS RECEIVED FROM THE USER STATING THAT NOTHING WAS LEFT INSIDE THE ENDOSCOPE FOLLOWING THE PROCEDURE. THE LOCATION OF THE LINK WIRE PORTION IS UNKNOWN. THE SUPPLIER IS WORKING ON IMPROVEMENTS TO CREATE A MORE ROBUST SOLDERING PROCESS TO PREVENT SOLDER JOINTS FROM BREAKING. THESE IMPROVEMENTS HAVE BEEN APPROVED AND ARE CURRENTLY PENDING NEW EQUIPMENT ARRIVAL PRIOR TO IMPLEMENTATION. PER THE SUPPLIER, ALL FORCEPS DEVICES ARE SUBJECTED TO A 100% TENSILE TEST AFTER SOLDERING AS WELL AS A AN ADDITIONAL TENSILE TEST OF THE COMPLETED DEVICE PRIOR TO FINAL QUALITY CONTROL INSPECTION. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING IN REGARDS TO PRODUCT INSPECTION: "BEGINNING AT THE HANDLE AND MOVING TOWARD THE CUPS, UNCOIL THE FORCEPS MAKING SURE NOT TO STRETCH THE CABLE. OPEN AND CLOSE THE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION. BECOME FAMILIAR WITH THE AMOUNT OF HANDLE MOVEMENT REQUIRED TO OPERATE THE CUPS. IF ANY IRREGULARITIES ARE NOTED, DO NOT USE. NOTE: EXERCISING THE HANDLE WHILE THE FORCEP IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE FORCEPS." PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED LARGE FORCEP-SPIKE 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 ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE BIOPSY FORCEPS WERE PLACED DOWN BIOPSY CHANNEL. THERE WAS DIFFICULTY OPENING TO OBTAIN A BIOPSY, THEN IT WAS NOTED THAT THE CUPS BROKE WHEN THEY FINALLY OPENED. THE FORCEPS WERE REMOVED FROM THE ENDOSCOPE AND THE BROKEN DRIVE WIRE FELL OUT. ALL PIECES ARE BEING RETURNED; NOTHING WAS LEFT INSIDE THE PATIENT'S BODY NOR THE ENDOSCOPE. ON 04/03/2017, AN EVALUATION RESPONSE LETTER WAS RECEIVED FROM THE APPROVED SUPPLIER. THE SUPPLIER EVALUATION FOUND THAT THE LINK WIRE TO DRIVE WIRE SOLDER JOINT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308653 CAPTURA SERRATED LARGE FORCEP-SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL COOK ENDOSCOPY 00827002560765

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF190 ENDOSCOPE