BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 6529285 · Received April 28, 2017

    Report

    Report Number
    1037905-2017-00236
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    February 24, 2017
    Report Date
    April 28, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    UDI-DI
    00827002561335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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. THE DEVICE WAS FUNCTION TESTED USING THE HANDLE AND THE CUPS WOULD OPEN BUT WOULD NOT CLOSE WHEN USING THE HANDLE. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE FORCEP WILL BE SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER PROVIDED THE FOLLOWING INFORMATION: ONE DEVICE FROM THE REPORTED EVENT WAS RETURNED IN A ZIP TYPE BAG WITH PROOF OF DECONTAMINATION. THE DEVICE HAS A BUTT JOINT THAT HAS BROKEN AT THE SOLDER CONNECTION. THE REPORTED DEFECT HAS BEEN CONFIRMED. THE DEVICE HISTORY RECORDS FOR PACKAGING WORK ORDER (PWO) WAS REVIEWED. THE PWO CONSISTED OF ONE ASSEMBLY ORDER (AO). DATE OF MANUFACTURE FOR THE ASSEMBLY ORDER (AOS) WAS NOVEMBER 30, 2016. NO 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 "WOULD NOT OPEN" WAS CONFIRMED; THE DEVICE WOULD OPEN BUT NOT CLOSE. THE ROOT CAUSE IS A BUTT JOINT WAS A BROKEN CONTROL WIRE / LINK WIRE SOLDER JOINT. THE SUPPLIER IS CURRENTLY WORKING ON IMPROVEMENTS TO CREATE A MORE ROBUST SOLDERING PROCESS TO PREVENT SOLDER JOINTS FROM BREAKING. THE INSTRUCTIONS FOR USE STATE: "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 BRONCH BIOPSY FORCEPS NO 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 A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK SERRATED FORCEPS WITH SPIKE. THE PHYSICIAN ADVANCED THE FORCEPS DOWN THE ENDOSCOPE. THE TECHNICIAN OPENED THE FORCEPS AND FELT A SNAP IN THE HANDLE, LIKE SOMETHING BROKE IN THE CATHETER. THE FORCEPS THEN WOULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310506 CAPTURA SERRATED FORCEPS WITH SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL COOK ENDOSCOPY 00827002561335

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS COLONOSCOPE (UNKNOWN MODEL)