BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2771376 · Received September 25, 2012

    Report

    Report Number
    1037905-2012-00537
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Report Date
    August 31, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TO COOK FOR EVALUATION. 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: 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 PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCE OF THIS NATURE. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED AT THE GASTROESOPHAGEAL JUNCTION. THE PHYSICIAN ATTEMPTED TO USE THE CLIP AND CLOSE DOWN ON THE AREA. HOWEVER, UPON TOUCHING THE TISSUE IT [THE CLIP] IMMEDIATELY FELL OFF [THE DEPLOYMENT DEVICE] IN THE PARTIALLY CLOSED POSITION. THE CLIP WAS LEFT TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. ANOTHER COOK DISPOSABLE HEMOSTASIS CLIP WAS OPENED AND TESTED PRIOR TO PATIENT CONTACT, BUT THE SAME DIFFICULTY OCCURRED. THE PHYSICIAN ELECTED TO USE A BOSTON SCIENTIFIC RESOLUTION CLIP TO COMPLETE THE PROCEDURE, BUT THIS CLIP FAILED AS WELL. A COOK SIX SHOOTER SAEED MULTI-BAND LIGATOR WAS USED TO FINISH THE PROCEDURE. THE PATIENT ID 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
    1 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W313400

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNKNOWN TYPE)