BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURA SERRATED LARGE FORCEPS - NO SPIKE

    MDR report key: 2181177 · Received July 21, 2011

    Report

    Report Number
    1037905-2011-00487
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(4). EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HEMORRHAGE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED LARGE FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A BIOPSY IN THE STOMACH, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS - NO SPIKE. BLEEDING OCCURRED AT THE BIOPSY SITE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT REQUIRED EMERGENCY ESOPHAGOGASTRODUODENOSCOPY (EGD) TO PERFORM HEMOSTASIS AT THE BIOPSY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA SERRATED LARGE FORCEPS - NO SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS GIF-Q160 ENDOSCOPE