BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 3820705 · Received April 10, 2014

    Report

    Report Number
    1037905-2014-00128
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 THE PROCEDURE, A COOK CAPTURA SERRATED FORCEPS WITH SPIKE WAS USED EITHER IN THE COLON, STOMACH OR ESOPHAGUS. WHILE DOING BIOPSIES THE FORCEPS ARE TEARING THE PATIENT'S TISSUE AND NOT TAKING A CLEAN BITE. THE FORCEPS DONT' CUT THE TISSUE AND WHEN THEY PULL THE FORCEPS, IT PULLS AND TEARS AND TISSUE WHICH LEADS TO MORE BLEEDING. MORE BLEEDING IS NOTICED THAN WHEN USING OTHER MANUFACTURER; DEVICES, HOWEVER NOT ENOUGH BLEEDING TO CALL FOR ADDITIONAL ACTION. AN EXACT QUANTITY WAS REQUESTED BUT WAS UNABLE TO BE SPECIFIED BY THE INITIAL REPORTER. ANOTHER COOK DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    216656 CAPTURA SERRATED FORCEPS WITH SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OLYMPUS ENDOSCOPE: MODEL # UNK