BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2974554 · Received January 29, 2013

    Report

    Report Number
    1037905-2013-00045
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE CLIP HAS BEEN DEPLOYED AND THE DRIVE WIRE IS ATTACHED INSIDE THE HANDLE. WITH HANDLE MANIPULATION, THE WIRE MOVES INSIDE THE SHEATH SMOOTHLY. THE HANDLE AND DRIVE WIRE FUNCTION AS INTENDED. THE CLIP WAS NOT INCLUDED IN THE RETURN. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVAL. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS OF THE RETURNED PRODUCT. INSTRUCTION FOR USE SATES: "ENDOSCOPE MUST REMAIN AS STRAIGHT AS POSSIBLE WHEN INSERTING OR WITHDRAWING DEVICE. CLOSE CLIP BY MOVING HANDLE SPOOL PROXIMALLY UNTIL CLIP IS FULLY CLOSED. CAUTION: DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCES, AS THIS MAY PREMATURELY DEPLOY CLIP". PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED. THE CLIP FELL OFF [INSIDE THE PT] AS THE DEVICE WAS EXITING THE END OF THE ENDOSCOPE. INFO REGARDING WHETHER THE DETACHED CLIP WAS OPENED OR CLOSED COULD NOT BE PROVIDED. THE ONLY SECTION OF THE DEVICE THAT REMAINED INSIDE THE PT'S BODY IS THE DETACHED CLIP. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURE 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
    39791 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC. W3206841

    Patients

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