BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS W/O SPIKE

    MDR report key: 9933057 · Received April 7, 2020

    Report

    Report Number
    1037905-2020-00166
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 9, 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 · 0

    INFORMATION REGARDING SECTION E3 - INITIAL REPORTER. OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT CONFIRMED THE COMPLAINT AS DESCRIBED BY THE USER. THE DEVICE WAS VISUALLY EXAMINED, AND THE CUPS APPEAR TO BE POTENTIALLY MISALIGNED. DURING A FUNCTIONAL TEST, THE HANDLE WAS MANIPULATED, AND THE CUPS WOULD OPEN AS INTENDED BUT DID NOT CLOSE AS INTENDED. THERE WAS NO RESISTANCE FELT IN THE HANDLE WHEN ACTUATING THE CUPS. HOWEVER, THERE IS A GAP IN BETWEEN THE CUPS AND THE TEETH DO NOT MESH CORRECTLY. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE WAS SENT BACK TO THE SUPPLIER FOR A FULL EVALUATION. 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. THE SUPPLIER PROVIDED THE FOLLOWING: VISUAL EVALUATION: THE TIP IS BENT. THE LENGTH WIRES WERE NOT EVEN DURING THE SOLDER PROCESS. THE CUPS ARE MISALIGNED. FUNCTIONAL EVALUATION: 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 CORRECTIVE ACTION WAS IMPLEMENTED IN NOVEMBER OF 2019. THE DATE OF MANUFACTURE FOR THE SUPPLIER LOT NUMBER INVOLVED WAS 02/2019. 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 CHECKLIST DID NOT INCLUDE RELEVANT DEFECTS. INVESTIGATION CONCLUSION: THE SUPPLIER PROVIDED THE FOLLOWING: THE 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 SUPPLIER LOT NUMBER INVOLVED WAS FEBRUARY 2019 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 AND WAS MANUFACTURED PRIOR TO CORRECTION IMPLEMENTATION. 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 · 0

    IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF THE DEVICE BENT AND THE CUPS WERE MISPLACED [MISALIGNED]. THERE WAS NO USE ON THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: UNKNOWN. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH PRODUCT EVALUATION INFORMATION.

    Description of Event or Problem · 1

    IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF THE DEVICE BENT AND THE CUPS WERE MISPLACED [MISALIGNED]. THERE WAS NO USE ON THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395530 CAPTURA SERRATED FORCEPS W/O SPIKE PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT PTS COOK ENDOSCOPY G56125 W4185429 00827002561250

    Patients

    Seq Age Sex Outcome Treatment
    1