BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE CYSTOSCOPIC FOREIGN BODY FORCEPS

    MDR report key: 2034687 · Received March 18, 2011

    Report

    Report Number
    1519132-2011-00011
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 18, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE INSTRUMENT FINDS THE DISTAL END OF THE PUSH ROD TO BE BROKEN FROM THE LINK ASSEMBLY. THE LINK ASSEMBLY AND RIVET IS STILL INTACT. THE DISTAL END OF THE PUSH ROD WAS NOT RETURNED WITH THE INSTRUMENT. THE DISTAL END OF THE FLEXIBLE SHAFT ASSEMBLY IS COMPLETELY SEVERED FROM THE JAW ASSEMBLY. THE FLEXIBLE SHAFT ASSEMBLY EXHIBITS SIGNS OF BEING STRETCHED APART AND TWISTED TO THE POINT OF MATERIAL FAILURE. THERE ARE NO OTHER SIGNS OF DAMAGE ON THE BALANCE OF THE INSTRUMENT. THE BROKEN DISTAL END OF THE PUSH ROD IS TYPICALLY AN INDICATION OF EXCESSIVE FORCE APPLIED TO THE DEVICE. THE BROKEN FLEXIBLE SHAFT ASSEMBLY IS ALSO A RESULT OF EXCESSIVE FORCE HAVING BEEN APPLIED. WITHOUT FURTHER INFORMATION FROM THE CUSTOMER, THE ASSESSMENT FINDS THE FAILURE DUE TO CUSTOMER MISUSE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE FLEXIBLE CYSTOSCOPIC FOREIGN BODY FORCEPS BROKE IN THE PATIENT, ALL PIECES WERE RETRIEVED FROM THE PATIENT WITHOUT ANY HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE CYSTOSCOPIC FOREIGN BODY FORCEPS FLEXIBLE CYSTOSCOPIC FOREIGN BODY FORCEP FCL GYRUS ACMI, INC. 332F10

    Patients

    Seq Age Sex Outcome Treatment
    1