BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDSCOPIC HEMOCLIP

    MDR report key: 3173439 · Received June 11, 2013

    Report

    Report Number
    1037905-2013-00383
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. 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 EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 MFG 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. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE FOR A RECTAL POLYP, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE GI TECHNICIAN NEEDED TWO HANDS AND A LOT OF STRENGTH WHEN TRYING TO DEPLOY THE CLIP. THE DEPLOYMENT DEVICE CLICKED LIKE THE CLIP DEPLOYED. THEY BELIEVED THE CLIP HAD DEPLOYED SO THE CATHETER OF THE DEPLOYMENT DEVICE WAS REMOVED. WHEN REMOVED, THEY FOUND THE CLIP WAS STILL ATTACHED AT THE END. THIS LED THEM TO BELIEVE THAT THE CLIP DID NOT CLOSE ALL THE WAY ONTO THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. [THE REPORTED OCCURRENCE OF PARTIAL CLIP CLOSURE SUGGESTS THE USER MAY HAVE EXPERIENCE DIFFICULTY WITH RELEASE OF THE CLIP FROM THE DEPLOYMENT DEVICE. THE REPORT OF AN AUDIBLE CLICK REASONABLY SUGGESTS THE DRIVE WIRE DISCONNECTED AT THE HANDLE.] 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 REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264956 INSTINCT ENDSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3240006

    Patients

    Seq Age Sex Outcome Treatment
    1