BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3161527 · Received May 5, 2013

    Report

    Report Number
    1037905-2013-00346
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE WAS NOT INVISIBLE IN THE COMPONENT ATTACHMENT INDICATING THE HOOK HAS BROKEN AT THE DISTAL END OF THE DRIVE WIRE. THE CLIP AND COMPONENT ATTACHMENT WERE SEPARATED TOGETHER AS A UNIT FROM THE DEPLOYMENT DEVICE. SINCE THE COMPONENT ATTACHMENT IS STILL SECURELY INSERTED INTO THE CLIP HOUSING, THE BROKEN PORTION OF THE HOOK MUST BE CONTAINED WITHIN THE CLIP AS IT HAS NO MEANS OF ESCAPE. 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. 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 ENDOSCOPY PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED ON A 6 MM POST-POLYPECTOMY SITE IN THE STOMACH. THE CLIP WAS ADVANCED THROUGH THE ENDOSCOPE AND CLOSED DOWN ONTO THE MUCOSA. WHEN PRESSING DOWN ON THE DEVICE, THE HANDLE BROKE. THE CLIP COULD NOT BE REOPENED FOR REMOVAL FROM THE MUCOSA. THE PHYSICIAN WAS ABLE TO MANEUVER AROUND AND THE CLIP CAME OFF THE MUCOSA IN THE CLOSED POSITION. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND AN ADDITIONAL 7 CLIPS MADE BY ANOTHER COMPANY WERE PLACED DUE TO THE CLIP COMING OFF AND TO FINISH THE ORIGINAL PLANNED CLIPPING PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PT'S BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. OTHER THAN PLACING ADDITIONAL CLIPS, THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE 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
    196174 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS EGD ENDOSCOPE (UNK MODEL NUMBER)