BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2210157 · Received August 4, 2011

    Report

    Report Number
    1037905-2011-00511
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 5, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K023903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO THE APPROVED CLIP SUPPLIER FOR EVAL. WE CONFIRMED THE HANDLE TO BE INOPERABLE. THE BOTTOM OF THE HANDLE SCREW COMPONENT THAT SECURES THE HANDLE TO THE DRIVE WIRE HAD BEEN DAMAGED AS A RESULT OF THE ASSEMBLY PROCESS AT THE SUPPLIER LEVEL. THE DRIVE WIRE EXHIBITED EVIDENCE THAT THE HANDLE SCREW COMPONENT HAD BEEN TIGHTENED APPROPRIATELY DURING THE ASSEMBLY PROCESS. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: THE RETURNED DEVICE WAS CONFIRMED TO BE DAMAGED AT THE SUPPLIER LEVEL. THE ROOT CAUSE IS MOST LIKELY AN INADEQUATELY SECURED DRIVE WIRE DUE TO A DAMAGED HANDLE SCREW COMPONENT. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL INSPECTION 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: THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS OCCURRENCE IN AN EFFORT TO HEIGHTEN AWARENESS. BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK DISPOSABLE HEMOSTASIS CLIP. THE CLIP WAS ABLE TO BE CLOSED ONTO THE TISSUE, BUT SOME RESISTANCE WAS ENCOUNTERED DURING CLOSING. THE USER FELT A SNAP AND THE HANDLE WAS UNABLE TO BE MOVED. THE CLIP COULD NOT BE RELEASED FROM THE DEPLOYMENT DEVICE AND REMAINED ATTACHED TO THE TISSUE SITE. WHEN THEY TRIED TO PULL THE CLIP TO REMOVE IT FROM THE PT, THE CLIP REMOVED SOME TISSUE. THE CLIP WAS ABLE TO BE OPENED UP BUT WOULD NOT FUNCTION PROPERLY. THE USER WAS ABLE TO PULL THE CLIP AND DEPLOYMENT DEVICE OUT OF THE ENDOSCOPE TO FACILITATE REMOVAL FROM THE PT. FOUR CLIPS WERE USED TO FINISH THE PROCEDURE. 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
    1 DISPOSABLE HEMOSTASIS CLIP MND LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3010015

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS PCF 160AL ENDOSCOPE