BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3180105 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00393
    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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE TWO (2) DEVICES DESCRIBED, ONLY ONE (1) DEVICE WAS MADE AVAILABLE FOR EVALUATION. 1037905-2013-00392: RETURNED ON (B)(6) 2013. 1037905-2013-00393: NOT AVAILABLE FOR EVALUATION. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. 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 EVALUATION. 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 OF 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 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 ENDOSCOPIC PROCEDURE IN THE LESSER CURVATURE OF THE STOMACH, THE PHYSICIAN SELECTED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WAS ATTACHED TO THE TISSUE SITE. THE NURSE HEARD A SLIGHT POP [DRIVE WIRE DISCONNECTED FROM HANDLE] WHEN TRYING TO RELEASE THE CLIP. THE CLIP DID NOT DEPLOY. THE CLIP WAS ABLE TO BE REOPENED FOR REMOVAL FROM THE CLIPPING SITE. WHEN THE GI TECHNICIAN REMOVED THE CATHETER [OF THE CLIP DEPLOYMENT DEVICE], THE CLIP WAS STILL ATTACHED AT THE END. THE CLIP WAS REMOVED FROM THE ENDOSCOPE AND REPLACED WITH A NEW CLIP. SEE MDR 1037905-2013-00392. THE SECOND COOK INSTINCT ENDOSCOPIC HEMOCLIP PROVIDED THE SAME RESULT AS THE FIRST. SEE MDR 1037905-2013-00393. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE THIRD COOK INSTINCT ENDOSCOPIC HEMOCLIP. 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
    268558 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3257183

    Patients

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