BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3222113 · Received July 2, 2013

    Report

    Report Number
    1037905-2013-00497
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 4, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE HAS SEPARATED INSIDE THE HANDLE. THE DEVICE WAS RETURNED WITHOUT THE CLIP; THEREFORE, A FUNCTIONAL TEST COULD NOT BE PERFORMED. THE PROXIMAL END OF THE DRIVE WIRE HAS BEEN ALTERED BY THE USER SO THE HANDLE SPOOL WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE SECURING COMPONENT TIP. THE TIP SHOWED DEFORMATION WHERE IT CONTACTED THE DRIVE WIRE, THUS INDICATING PROPER ASSEMBLY OF THE SECURING COMPONENT. THE DRIVE WIRE WAS REMOVED FROM THE DEVICE, VISUALLY EXAMINED AND DETERMINED THAT THE DRIVE WIRE WAS CORRECTLY MANUFACTURED. THE HOOK OF THE DRIVE WIRE IS INTACT. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB 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. 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 CONFORMED 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. THE CLIP WAS ATTACHED TO THE TISSUE BUT WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. THE [DRIVE] WIRE SNAPPED OFF THE HANDLE. SEPARATION [OF THE CLIP FROM THE DEPLOYMENT DEVICE] WAS ACHIEVED BY WRAPPING THE BROKEN [DRIVE] WIRE AROUND HEMOSTATS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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
    300591 INTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3261780

    Patients

    Seq Age Sex Outcome Treatment
    1 COLONOSCOPE, MAKE/MODEL UNK