BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE RETRIEVAL GRASPING FORCEPS

    MDR report key: 1994966 · Received February 17, 2011

    Report

    Report Number
    3005099803-2011-00354
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 27, 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

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT THE PRONGS WOULD NOT OPEN DUE TO KINKS IN THE INNER AND OUTER SHEATHS, DRIVE WIRE, AND HANDLE CANNULA. MOST LIKELY, DUE TO SOME ASPECT OF THE PATIENT¿S ANATOMY OR WHILE MANEUVERING THE DEVICE, THE WORKING LENGTH BECAME KINKED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON STONE RETRIEVAL GRASPING FORCEPS WAS USED IN A STONE REMOVAL PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE FORCEPS WAS NOT OPENING AND CLOSING PROPERLY AND THE WIRE BUCKLED WITHIN THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETELY WITH A SECOND TALON STONE RETRIEVAL GRASPING FORCEPS. IT IS UNCONFIRMED IF A STONE REMAINED IN THE FORCEPS WHEN THE DEVICE WAS REMOVED. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON STONE RETRIEVAL GRASPING FORCEPS WAS USED IN A STONE REMOVAL PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE FORCEPS WAS NOT OPENING AND CLOSING PROPERLY AND THE WIRE BUCKLED WITHIN THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETELY WITH A SECOND TALON STONE RETRIEVAL GRASPING FORCEPS. IT IS UNCONFIRMED IF A STONE REMAINED IN THE FORCEPS WHEN THE DEVICE WAS REMOVED. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    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 M0063701190 13852627

    Patients

    Seq Age Sex Outcome Treatment
    1