BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS W/O SPIKE

    MDR report key: 9933381 · Received April 7, 2020

    Report

    Report Number
    1037905-2020-00168
    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

    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 BENT WAS NOT CONFIRMED. THE CUPS ARE MISALIGNED. FUNCTIONAL EVALUATION: WHEN THE HANDLE WAS ACTUATED THE TIP DID OPEN AND CLOSE. HOWEVER, THE CUPS WERE MISALIGNED SO NO FURTHER EVALUATION WAS PERFORMED. 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 INCLUDE RELEVANT DEFECTS. THERE WERE REJECTS FOR MISALIGNED CUPS IN THE ASSEMBLY ORDER. INVESTIGATION CONCLUSION: THE SUPPLIER PROVIDED THE FOLLOWING: THE ASSIGNABLE CAUSE OF THE MISALIGNED CUPS WAS NOT DETERMINED. THEREFORE, NO CORRECTIVE ACTION HAS BEEN ASSIGNED. 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 REMOTE. 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 · 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
    396795 CAPTURA SERRATED FORCEPS W/O SPIKE PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT PTS COOK ENDOSCOPY G56125 W4217560 00827002561250

    Patients

    Seq Age Sex Outcome Treatment
    1