BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS W/O SPIKE

    MDR report key: 9990626 · Received April 23, 2020

    Report

    Report Number
    1037905-2020-00186
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 31, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PTS
    UDI-DI
    00827002561250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCTS SAID TO BE INVOLVED CONFIRMED THE REPORT. DEVICE ONE (1), THE CUPS OPENED AND CLOSED AS DESIGNED, HOWEVER THE CUPS APPEARED POTENTIALLY MISALIGNED. DEVICE TWO (2) THE CUPS OPENED AND CLOSED, HOWEVER THE CUPS WOULD NOT CLOSE FULLY ON ONE SIDE WHEN THE HANDLE WAS HELD IN THE CLOSED POSITION. DEVICE THREE (3) THE CUPS OPENED AND CLOSED, HOWEVER IT WAS NOTED THAT THE CUPS WERE POTENTIALLY MISALIGNED AND THE CUPS WOULD NOT CLOSE FULLY WHEN THE HANDLE WAS HELD IN THE CLOSED POSITION. NO OTHER ANOMALIES WERE DISCOVERED WITH THE DEVICE. THE FORCEPS WERE SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCTS THAT WERE RELEASED FOR DISTRIBUTION. THE SUPPLIER PROVIDED THE FOLLOWING: VISUAL EVALUATION: DEVICE ONE (1): THE TIP IS BENT. THE CUPS ARE MISALIGNED. DEVICE TWO (2): THE TIP IS BENT. THE CUPS ARE MISALIGNED. DEVICE THREE (3): THE TIP IS BENT. THE CUPS ARE MISALIGNED. FUNCTIONAL EVALUATION: DEVICE ONE: (1) WHEN THE HANDLE WAS ACTUATED THE TIP DID OPEN AND CLOSE. HOWEVER, THE TIP IS BENT TO ONE SIDE CAUSING THE CUPS TO BE MISALIGNED. DEVICE TWO (2): WHEN THE HANDLE WAS ACTUATED THE TIP DID OPEN AND CLOSE. HOWEVER, THE TIP IS BENT TO ONE SIDE CAUSING THE CUPS TO BE MISALIGNED. DEVICE THREE (3): WHEN THE HANDLE WAS ACTUATED THE TIP DID OPEN AND CLOSE. HOWEVER, THE TIP IS BENT TO ONE SIDE CAUSING THE CUPS TO BE MISALIGNED. ADDITIONAL COMMENTS: THE ROOT CAUSE OF THE BENT TIP IS THE UNEVEN POSITIONING OF THE LINK WIRES DURING THE SOLDERING PROCESS. A CORRECTIVE ACTION WAS ISSUED TO ADDRESS THIS FAILURE MODE. A FIXTURE WAS DEVISED TO REDUCE THE MOVEMENT OF THE WIRES DURING THE SOLDERING PROCESS. THE DEVICE HISTORY RECORDS FOR PACKAGING WORK ORDER (PWO) WERE REVIEWED. THE PWO CONSISTED OF ONE ASSEMBLY ORDER (AO). THE MANUFACTURING RECORDS AND/OR FINAL QUALITY CONTROL (FQC) CHECKLIST DID INCLUDE RELEVANT DEFECTS. THERE WERE 5 REJECTS FOR MISALIGNED CUPS IN THE ASSEMBLY ORDER. INVESTIGATION CONCLUSION: THE SUPPLIER PROVIDED THE FOLLOWING: CORRECTIVE ACTION: A CORRECTIVE ACTION WAS INITIATED NOVEMBER 2019. SPECIFICALLY A FIXTURE WAS FABRICATED TO ASSIST THE OPERATORS WITH HOLDING THE DEVICE DURING SOLDERING OF THE LINK WIRES. THE DATE OF MANUFACTURE FOR THE LOT WAS JUNE2019 WHICH WAS PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTION. PRIOR TO DISTRIBUTION, ALL COOK CAPTURA SERRATED FORCEPS W/O 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. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. 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

    IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED THREE (3) COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF CUPS WERE BENT. IT WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 31MARCH 2020, THE DEVICES WERE EVALUATED AND TWO (2) DEVICES WERE EVALUATED AND FOUND TO BE POTENTIALLY MISALIGNED AND ONE (1) DEVICE THE CUPS WOULD NOT CLOSE FULLY ON ONE SIDE WHEN THE HANDLE WAS HELD IN THE CLOSED POSITION. THE SUPPLIER FOUND THAT ALL THREE (3) DEVICES WERE MISALIGNED (SUBJECT OF REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454170 CAPTURA SERRATED FORCEPS W/O SPIKE PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT PTS COOK ENDOSCOPY G56125 W4229704 00827002561250

    Patients

    Seq Age Sex Outcome Treatment
    1