BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSTITCH SUTURING DEVICE

    MDR report key: 2548694 · Received April 11, 2012

    Report

    Report Number
    3006524618-2012-00403
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    PMA / PMN Number
    K042031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE PATIENT'S AGE AND GENDER WERE REQUESTED BUT WERE NOT RECEIVED. REFERENCE MANUFACTURERS REPORT(S): 9019871-2012-00402, 9019871-2012-00404, 9019871-201-0045.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE PHYSICIAN WAS UTILIZING A SPEEDSTITCH SUTURING DEVICE AND UNKNOWN SPEEDSTITCH SUTURE CARTRIDGE. UPON LOADING THE CARTRIDGE INTO THE SPEEDSTITCH HANDLE THE CARTRIDGE WOULD NOT STAY INSIDE THE SHAFT. THE DOCTOR UTILIZED TWO OTHER HANDLES AND AGAIN THE CARTRIDGE WOULD NOT STAY IN THE SHAFT. THE PROCEDURE WAS COMPLETED BY MANUALLY MANIPULATING THE WINGS OF THE SUTURE CARTRIDGE TO FIT THE SHAFT OF THE SPEEDSTITCH HANDLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSTITCH SUTURING DEVICE SUTURE DEVICE; ENDOSCOPIC ACCESSORIES GAT ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention