BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABSORBATACK 5MM SINGLE USE ABSORBABLE

    MDR report key: 1213664 · Received June 20, 2008

    Report

    Report Number
    1219930-2008-00471
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 14, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    OCW
    PMA / PMN Number
    K071061
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR ANALYSIS AT THE QA LAB. QA EXAMINED ONE CLINICAL PARTIALLY APPLIED ABSORBATACK 5MM INSTRUMENT AND WAS UNABLE TO DETECT ANY DISCREPANCIES RELATED TO COMPONENTS OR MFR OF THE PRODUCT. THE DEVICE WAS RECEIVED WITH A TACK PROTRUDING FROM THE DISTAL TUBE. DURING A FUNCTIONAL EXAMINATION, THE ABSORBABLE TACKS DEPLOYED FROM THE TUBE UPON HANDLE ACTUATION; HOWEVER THE TACKS DID NOT SEAT PROPERLY DUE TO A DISRUPTED TIMING OF THE INSTRUMENT. UPON DISASSEMBLY OF THE CLINICAL DEVICE THE FOLLOWING OBSERVATIONS WERE NOTED: THE DEVICE TIMING WAS OFF AND THE GEAR AT THE PROXIMAL END OF THE TUBE SHAFT WAS SLIGHTLY STRIPPED. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE RATCHETING GEAR WAS OFF TIMING WITHIN THE DEVICE HANDLE. THE TACK DID NOT ADVANCE PROPERLY DURING HANDLE ACTUATION DUE TO THE OBSERVED GEAR DAMAGE AND INCORRECT TIMING OF THE INSTRUMENT. THE REPORTED CONDITION WAS A RESULT OF MISUSE OF THE DEVICE AND THE FAILURE IS ATTRIBUTED TO USER ERROR. REPLICATION OF THESE CONDITIONS MAY OCCUR DUE TO THE FOLLOWING: IF THE HANDLE IS NOT FULLY COMPRESSED DURING FIRING, PRIOR TO A SECOND HANDLE COMPRESSION, THIS WILL OFFSET THE GEAR TIMING AND RESULT IN IMPROPER TACK DEPLOYMENT. IF THE INSTRUMENT TUBE SHAFT IS APPLIED IN TO THE CLINICAL SITE WITH EXCESS SIDE LOAD DURING THE APPLICATION, THIS MAY RESULT IN THE BENDING OF THE DISTAL OUTER TUBE SHAFT, CREATING RESISTANCE DURING TACK DEPLOYMENT AND HANDLE ACTUATION, THEREFORE DAMAGING THE INTERNAL GEAR COMPONENTS AND INTERFERING WITH PROPER TACK PLACEMENT. PLEASE NOTE, THE DEVICE MUST BE APPLIED WITH THE DISTAL TUBE SHAFT FLUSH TO THE MESH WITHIN THE OPERATIVE SITE, AND A SINGLE COMPLETE HANDLE COMPRESSION MUST BE PERFORMED TO ENSURE THE PROPER DEPLOYMENT AND SEATING OF EACH ABSORBABLE TACK.

    Description of Event or Problem · 1

    PROCEDURE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED BUT THE ABSORBABLE TACK DID NOT ANCHOR THE MESH DESPITE SEVERAL ATTEMPTS BY THE SURGEON. ANOTHER BRAND WAS USED SUCCESSFULLY, THERE WAS NO PT OR STAFF HARM. THE SURGERY TIME WAS NOT SIGNIFICANTLY EXTENDED AND THERE WAS NO REPORT OF FURTHER COMPLICATION. THIS REPORT WAS PREPARED IN RESPONSE TO FDA REQUEST DATED 5/22/08 WITH MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBATACK 5MM SINGLE USE ABSORBABLE SURGICAL FIXATION DEVICE OCW NORTH HAVEN - USS * U8C06

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR