BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 5682748 · Received May 26, 2016

    Report

    Report Number
    1030451-2016-00009
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    April 27, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    HFX
    PMA / PMN Number
    K040052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) AS A REPACKAGER AND PRIVATE LABEL DISTRIBUTOR ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) TO FINE SURGICAL INSTRUMENTS, INC. ON 05/23/2016 REPORTING THE COMPLAINT ISSUE. THE MANUFACTURER HAS JUST RECEIVED THIS COMPLAINT FOR INVESTIGATION INITIATION AT THIS TIME AND THEY DO NOT HAVE ANY INVESTIGATION CONCLUSIONS AVAILABLE YET. (B)(4) HAS USED THE CLAMP IN CONVENIENCE KITS AND REPACKAGED THE ITEM SINCE 2010. WE HAVE REVIEWED OUR COMPLAINT DATABASE AND HAVE FOUND NO OTHER RELATED COMPLAINTS. BASED ON OUR TRENDING ANALYSIS, THIS APPEARS TO BE ISOLATED. CURRENT INVENTORY INSPECTION OF THE INSTRUMENT MEETS SPECIFICATIONS. THE INVENTORY EVALUATED TIGHTENED AND LOOSENED APPROPRIATELY.

    Description of Event or Problem · 1

    (B)(4) IS A REPACKAGER AND PRIVATE LABEL DISTRIBUTOR OF THE GOMCO CLAMP. THE CLAMP IS MANUFACTURED BY FINE SURGICAL INSTRUMENTS AS VENDOR PART (B)(4). (B)(4) RECEIVED A COMPLAINT FROM (B)(6) ON (B)(6) 2016 THAT HOSPITAL STAFF HAD REPORTED THAT A GOMCO CLAMP WAS NOT CLAMPING DOWN PROPERLY AND WAS NOT LOOSENING/TIGHTENING PROPERLY. MEDICAL ACTION INDUSTRIES CONTACTED THE HOSPITAL FOR ADDITIONAL INFORMATION REGARDING ANY ASSOCIATED ADVERSE EVENTS. THE HOSPITAL RESPONDED ON (B)(6) 2016 THAT THERE WAS EXTRA BLEEDING ASSOCIATED WHICH WARRANTED INTERVENTION. ON 05/25/2016, THE PHYSICIAN FURTHER CLARIFIED THAT THE GOMCO CLAMP WAS DIFFICULT TO TIGHTEN. ONCE IT WAS TIGHTENED, IT WAS VERY DIFFICULT TO GET OFF. THIS RESULTED IN EXCESSIVE BLEEDING WHICH REQUIRED A UROLOGIST COMING IN TO PLACE SUTURES. (B)(4) NOTIFIED FINE SURGICAL INSTRUMENTS ON 05/23/2016 BY SUPPLIER CORRECTIVE ACTION REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337567 MEDICAL ACTION INDUSTRIES INSTRUMENT: CLAMP GOMCO 1.3 HFX MEDICAL ACTION INDUSTRIES 71375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention