BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURA SERRATED FORCEPS WITH SPIKE

    MDR report key: 3761079 · Received April 10, 2014

    Report

    Report Number
    1037905-2014-00129
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FCL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR INITIAL LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED WAS UNABLE TO CONFIRMED THE REPORT AS DESCRIBED. AS RECEIVED, THE FORCEPS WOULD NOT OPEN, HOWEVER, THE CUPS ARE IN ALIGNMENT WITH EACH OTHER. UPON PERFORMING THE INITIAL REVIEW, A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. THIS DEVICE HAS BEEN RETURNED TO THE APPROVED SUPPLIER FOR FURTHER EVAL. A F/U REPORT WILL BE ISSUED ONCE THE SUPPLIER HAS PROVIDED THEIR FINDINGS. 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. INVESTIGATION CONCLUSIONS: WE CANNOT ADEQUATELY DETERMINED A ROOT CAUSE AT THIS TIME BECAUSE THE INVESTIGATION IS STILL IN PROCESS AT OUR APPROVED SUPPLIER. 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. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ADVANCE THE FORCEPS INTO THE TISSUE AT THE DESIRED BIOPSY SITE. THEN THE USER IS INSTRUCTED TO CLOSE THE FORCEPS AROUND THE TISSUE WHILE USING SLIGHT PRESSURE ON THE HANDLE. THE USER IS INSTRUCTED TO MAINTAIN GENTLE HANDLE PRESSURE TO KEEP THE CUPS CLOSED AND GENTLY WITHDRAW THE FORCEPS FROM THE SITE. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED FORCEPS WITH SPIKE WAS SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONCLUDED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA 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 COLONOSCOPY, A COOK CAPTURA SERRATED FORCEPS WITH SPIKE WAS USED. THEY TOOK A BITE OF TISSUE IN THE CECUM AND THE BITE WAS LARGER THAN EXPECTED. THERE WAS ALSO SOME BLEEDING THAT HAD STOPPED WITH A HEMOSTASIS CLIP. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. OTHER THAN THE PACEMAKER OF A HEMOSTASIS CLIP, THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216211 CAPTURA SERRATED FORCEPS WITH SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC. W3380227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS COLONOSCOPE (UNK MODEL NUMBER)