BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3189520 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00395
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE HOOK IS BROKEN AT THE DISTAL END OF THE DRIVE WIRE. THE CLIP COMPONENT ATTACHMENT AND BROKEN PORTION OF THE HOOK WERE NOT RETURNED WITH THE DEVICE. THE DRIVE WIRE MOVES FREELY IN THE SHEATH AND THE PROXIMAL END OF THE DRIVE WIRE REMAINS SECURELY ATTACHED TO THE HANDLE SPOOL. 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 THE 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 HANDLE. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO VERIFY SMOOTH HANDLE OPERATION AND CLIP OPERATION PRIOR TO USE. INSTRUCTION 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. CORRECTION 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 THE COLONOSCOPY PROCEDURE, TWO (2) COOK INSTINCT ENDOSCOPIC HEMOCLIPS WERE USED IN THE RECTUM ON A 6MM TARGET SITE. THE FIRST CLIP WAS ATTACHED TO THE TISSUE. THE CLIP WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. FINALLY, THE HOOK ON THE END OF THE CLIP [DRIVE WIRE] BROKE, ALLOWING THE CLIP TO RELEASE. SEE MDR 103790-2013-00394. THE SECOND CLIP WAS ATTACHED TO THE TISSUE SITE. THIS CLIP ALSO WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. THIS CLIP COULD NOT BE REOPENED FOR REMOVAL. THE CLIP WAS PULLED OUT [OFF THE TISSUE SITE] AND THE PROCEDURE WAS COMPLETED.. OUR LABORATORY EVAL CONFIRMED A SMALL SECTION OF THE BROKEN PORTION OF THE HOOK AT THE DISTAL END OF THE DRIVE WIRE HAS DETACHED FROM BOTH DEVICES. INFO REGARDING THE MISSING SECTIONS WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE OF THE MISSING SECTIONS IS UNK. THE INITIAL RPTR STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVAL IS UNK. 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
    269835 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3257136

    Patients

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