BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2843519 · Received November 19, 2012

    Report

    Report Number
    1037905-2012-00644
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    WILSON COOK MEDICAL, INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION 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. 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 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. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 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 A SCREENING COLONOSCOPY WITH POLYPECTOMY, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED. A HOT SNARE POLYPECTOMY WAS DONE ON A 1CM POLYP IN THE CECUM. THE PRACTIONER ATTEMPTED TO UTILIZE A DISPOSABLE HEMOSTASIS CLIP TO APPROXIMATE THE MARGINS OF THE POLYPECTOMY SITE AND FOR MANAGEMENT OF OOZING (BLEED). HOWEVER, THE CLIP WAS UNABLE TO BE RELEASED AFTER DEPLOYMENT (ATTACHED TO TISSUE SITE) INDICATIVE OF DEVICE FAILURE. THE CLIP HAD TO BE PULLED OFF THE COLON AND A BIPOLAR CAUTERY DEVICE WAS USED TO CONTROL THE BLEED AND FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. EXCESSIVE BLEEDING OCCURRED AND A BIPOLAR CAUTERY DEVICE WAS USED TO ACHIEVE HEMOSTASIS. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURENCE. WE REQUESTED CLARIFICATION REGARDING THE ALLEGED CAUSE OF THE EXCESSIVE BLEEDING THAT WAS REPORTED. THE INITIAL REPORTER AT THE MEDICAL FACILITY INDICATED THAT THE EXCESSIVE BLEEDING WAS CAUSED BY REMOVAL OF THE CLOSED CLIP FROM THE TISSUE SITE. THE CLIP HAD TO BE PULLED OFF A SITE THAT WAS ALREADY BLEEDING. WHEN ASKED IF ADD'L PROCEDURES WERE REQUIRED, THE MEDICAL FACILITY INDICATED THE PT WAS PENDING TREATMENT FOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125310 DISPOSABLE HEMOSTASIS CLIP MND WILSON COOK MEDICAL, INC. W3153128

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention