BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE OPTICAL GRASPING FORCEPS

    MDR report key: 2427828 · Received January 10, 2012

    Report

    Report Number
    1519132-2011-00040
    Event Type
    Other
    Date Received
    January 10, 2012
    Date of Event
    November 24, 2011
    Report Date
    December 12, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY. A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT WITH THE SAME OR SIMILAR VERBIAGE IN THE PROBLEM DESCRIPTION REVEALS A COMMON ROOT CAUSES AS FOLLOWS: THE FAILURE OF THIS INSTRUMENT WAS LIKELY A BROKEN JAW, CAUSED BY EXCESSIVE FORCE EXERTED BY THE CUSTOMER DURING USE. THE IFU WARNS AGAINST THIS MISUSE IN THE CAUTIONS SECTION AS FOLLOWS: EXCESSIVE SQUEEZING FORCE ON HANDLES CAN LEAD TO FAILURE OF FORCEPS JAWS.

    Description of Event or Problem · 1

    PT UNDERGOING PROCEDURE FOR REMOVAL AND REPLACEMENT OF RETAINED URETERAL STENT. THE SURGEON WAS UTILIZING A CIRCON GRASPING FORCEP TO REMOVE A PIECE OF THE CALCIFIED STENT WHEN ONE OF THE GRASPER JAWS BROKE OFF OF THE INSTRUMENT. THE BROKEN PIECE WAS RETRIEVED AND A NEW INSTRUMENT WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT. BROKEN DEVICE WAS RETURNED TO THE USER FACILITY STERILE PROCESSING DEPT FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE OPTICAL GRASPING FORCEPS OPTICAL GRASPING FORCEPS GEN GYRUS ACMI, INC. E8215

    Patients

    Seq Age Sex Outcome Treatment
    1