BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2844750 · Received November 1, 2012

    Report

    Report Number
    1037905-2012-00602
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    WILSON COOK MEDICAL, INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. UNUSED PRODUCT WAS RETURNED IN SEALED POUCHES. A FUNCTIONAL TEST WAS CONDUCTED ON THESE DEVICES. THEY WERE ADVANCED THROUGH A PENTAX EC3840TL COLONOSCOPE (2.8MM CHANNEL) PLACED IN A SIMULATED LOWER GI POSITION WITH THE ENDOSCOPE TIP RETROFLEXED. THIS REPRESENTS THE WORST CASE SCENARIO. ALL THE CLIPS OPENED AND CLOSED ON A SIMULATED TISSUE SAMPLE. THE CLIPS DEPLOYED AND REMAINED ATTACHED TO THE SIMULATED TISSUE SAMPLE. A VISUAL EXAMINATION OF THE CLIPS HOUSING WERE CONDUCTED. TWELVE DEVICES HAD CRACKS IN THE HOUSING PRIOR TO DEPLOYING THE CLIPS. THE CLIPS WERE RE-EXAMINED AFTER DEPLOYMENT AND IT WAS OBSERVED THAT THERE WAS 6 ADD'L DEVICES THAT HAD CRACKS IN THE HOUSING. THE DEVICE HISTORY RECORDS FOR THE LOT NUMBERS OF THE UNUSED PRODUCT WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: PRIOR TO DISTRIBUTION, ALL HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT SAID TO BE INVOLVED AND THE UNUSED PRODUCT ARE INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY PROCEDURE, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED. AFTER DEPLOYMENT OF THE CLIP TO A POLYPECTOMY SITE, THE CLIP IS NOT GRABBING AND ADHERING TO THE TISSUE. THE CLIP IS ATTACHED AND THEN WITHIN SECONDS AFTER DEPLOYMENT, THE CLIP FLIPS OFF THE TISSUE IN THE CLOSED POSITION. THE FACILITY USED ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. 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
    1 DISPOSABLE HEMOSTASIS CLIP MND WILSON COOK MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1