BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    MDR report key: 4093175 · Received August 21, 2014

    Report

    Report Number
    1037905-2014-00328
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 23, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER COULD NOT BE SPECIFIED BY THE INITIAL REPORTER. UPON REVIEW OF THIS FACILITY'S ORDER HISTORY, WE CONFIRMED THE OCCURRENCE INVOLVES ONE OF THE FOLLOWING LOT NUMBERS: W3434914, MANUFACTURE DATE 05/30/2014, EXPIRATION DATE, 05/30/2017. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS FOR THE TWO POTENTIAL LOT NUMBERS WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE SIZE OF TISSUE SAMPLE OR BIOPSY TO BE EXCISED CAN BE CONTROLLED BY HOW THE USER HANDLES THE FORCEPS. IF EXCESSIVE PRESSURE WAS APPLIED DURING ADVANCEMENT INTO THE TISSUE OR DURING HANDLE MANIPULATION, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED LARGE FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE TWO POTENTIAL DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS 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 · 1

    DURING THE PROCEDURE, A COOK CAPTURA SERRATED LARGE FORCEPS WITH SPIKE WAS USED. A BIOPSY WAS TAKEN AND THEY NOTICED THE CUPS HAD MORE OF A TEARING MOTION INSTEAD OF A CUTTING MOTION. UPON FURTHER INSPECTION OUTSIDE OF THE ENDOSCOPE, THE CUPS WERE MISALIGNED OR HAD A CROSS-BITE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506742 CAPTURA SERRATED LARGE FORCEP-SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC. W3441158

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)