BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE RETRIEVAL GRASPING FORCEPS

    MDR report key: 1972441 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00131
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE DEVICE OPENED AND CLOSED, HOWEVER IT WAS UNABLE TO CAPTURE THE STONE. THERE WERE NO VISIBLE PROBLEMS WITH THE DEVICE, AND NO STONE WAS IN THE DEVICE WHEN THE PROBLEM OCCURRED. THE INTENDED STONE WAS APPROXIMATELY 3MM IN SIZE. IT IS ALSO NOTED THAT THE FAILURE OF "UNABLE TO CAPTURE STONE" IS NOT A MEDWATCH REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON 3 PRONG STONE RETRIEVAL GRASPING FORCEPS WAS USED IN A RIGID URETEROSCOPY PROCEDURE ON A MALE PATIENT. ACCORDING TO THE COMPLAINANT, AFTER LASERING WHILST REMOVING FRAGMENTED STONES, SURGEON EXPRESSED CONCERN AS THE FORCEP WAS NOT GRASPING ONTO STONE AS IT SHOULD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND TALON 3 PRONG STONE RETRIEVAL GRASPING FORCEPS. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON 3 PRONG STONE RETRIEVAL GRASPING FORCEPS WAS USED IN A RIGID URETEROSCOPY PROCEDURE ON A MALE PATIENT.ACCORDING TO THE COMPLAINANT, AFTER LASERING WHILST REMOVING FRAGMENTED STONES, SURGEON EXPRESSED CONCERN AS THE FORCEP WAS NOT GRASPING ONTO STONE AS IT SHOULD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND TALON 3 PRONG STONE RETRIEVAL GRASPING FORCEPS. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE RETRIEVAL GRASPING FORCEPS DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063701100 13683777

    Patients

    Seq Age Sex Outcome Treatment
    1