BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3252409 · Received July 24, 2013

    Report

    Report Number
    1037905-2013-00574
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE DRIVE WIRE WAS NOT VISIBLE IN THE COIL ASSEMBLY 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 MAY BE ENCOUNTERED WHILE ATTEMPTING TO CLOSE AND/OR DEPLOY THE CLIP AND CAN LEAD TO DAMAGE OF DEVICE COMPONENTS SUCH AS THE HOOK AT THE DISTAL END OF THE DRIVE 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 CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE 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 UPPER ENDOSCOPY PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. THEY ATTACHED THE CLIP TO THE TISSUE SITE. THEY THEN OPENED THE CLIP TO READJUST THE PLACEMENT. HOWEVER, THE CLIP WAS UNABLE TO BE CLOSED AGAIN. THE CLIP WAS REMOVED W/O HARM TO THE PT AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. OUR EVAL OF THE DEVICE CONFIRMED THE DRIVE WIRE IS BROKEN AT THE CLIP END. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344700 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3264315

    Patients

    Seq Age Sex Outcome Treatment
    1 FUJINON ENDOSCOPE (UNK TYPE)