BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3152522 · Received June 4, 2013

    Report

    Report Number
    1037905-2013-00345
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 WAS NOT PROVIDED TO COOK FOR EVALUATION. 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 EVALUATION. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOW PRECAUTION - "IF CLIP DEPLOYMENT DEVICE SI USED WITH ENDOSCOPE IN TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR". THE INSTRUCTIONS FOR USE ALSO STATES "IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP". PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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 CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A GI ENDOSCOPY PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. THE CLIP MALFUNCTIONED. THE CLIP PARTIALLY DEPLOYED BUT THE USER WAS UNABLE TO RELEASE IT FROM THE DEPLOYMENT DEVICE. THIS REQUIRED THE CLIP TO BE REMOVED FROM THE POLYPECTOMY SITE AND THIS CAUSED TEARING OF THE TISSUE. AN ADDITIONAL CLIP WAS REQUIRED FOR INTERVENTION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. OTHER THAN PLACING AN ADDITIONAL CLIP DURING THE SAME PROCEDURE, THE PATIENT DID 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 OTHER THAN TEARING OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247035 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257130

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)