BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3212738 · Received July 3, 2013

    Report

    Report Number
    1037905-2013-00513
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE WAS NOT VISIBLE IN THE CATHETER COMPONENT INDICATING THE HOOK HAS BROKEN AT THE DISTAL END OF THE DRIVE WIRE. THE CLIP WAS REMOVED AND THE BROKEN PORTION OF THE HOOK WAS LOCATED WITHIN THE CLIP HOUSING. THEREFORE, ALL THE PIECES OF THE DEVICE ARE ACCOUNTED FOR. THE DRIVE WIRE IS SECURELY ATTACHED TO THE HANDLE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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: RESISTANCE ENCOUNTERED WHILE ATTEMPTING TO DEPLOY THE CLIP AFTER THE CLIP IS CLOSED ON THE TISSUE (I.E. DIFFICULTY WITH CLIP RELEASE) CAN LEAD TO DAMAGE OF DEVICE COMPONENTS SUCH AS THE HOOK AT THE DISTAL END OF THE DRIVE WIRE OR THE SECURITY OF THE DRIVE WIRE TO THE HANDLE. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO VERIFY SMOOTH HANDLE OPERATION AND CLIP OPERATION PRIOR TO USE. INSTRUCTIONS FOR USE STATES TO PERMANENTLY DEPLOY CLIP, PULL HANDLE SPOOL TOWARD HANDLE THUMB RING UNTIL CLIP DETACHES. NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP. INSTRUCTIONS FOR USE STATES IF CLIP DEPLOYMENT DEVICE IS USED WITH ENDOSCOPE IN A TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE FIRST CLIP DEPLOYED ONTO THE TISSUE SITE BUT FELL OFF IN A CLOSED POSITION. SEE MDR 1037905-2013-00512. THE SECOND CLIP WAS ATTACHED TO THE TISSUE SITE, BUT WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. THE CLIP COULD NOT BE REOPENED AND HAD TO BE PULLED OFF THE TISSUE SITE. TWO ADDITIONAL CLIPS WERE REQUIRED IN RESPONSE TO PULLING THE CLIP OFF THE TISSUE. SEE MDR 1037905-2013-00513. NO PART OF THE DEVICES REMAINED INSIDE THE PATIENT'S BODY. THE FIRST CLIP FELL OFF IN A CLOSED POSITION IN THE PATIENT (SEE MDR 1037905-2013-00512). DUE TO THE PERFORMANCE OF THE SECOND CLIP (SEE MDR 1037905-2013-00513), TWO ADDITIONAL CLIPS WERE PLACED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THESE OCCURRENCES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THESE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305901 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPIC (UNKNOWN MODEL NUMBER)