BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3983287 · Received July 3, 2014

    Report

    Report Number
    1037905-2014-00273
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FHN
    PMA / PMN Number
    K132809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. 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 DEVISE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULT AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE PHYSICIAN WAS ATTEMPTING TO CLOSE A POLYPECTOMY SITE WHILE IN THE CECUM. UPON ATTEMPTING TO DEPLOY THE CLIP, THE CLIP WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN WAS ABLE TO DEPLOY THE CLIP ON TO THE SITE TO COMPLETE THE PROCEDURE. OTHER THAN THE INTENDED CLIP, 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
    392036 INSTINCT ENDOSCOPIC HEMOCLIP FHN WILSON-COOK MEDICAL INC. W3403656

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS PCF160 ENDOSCOPE