BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICEP¿

    MDR report key: 2222573 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02845
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED TALON STONE RETRIEVAL GRASPING FORCEPS REVEALED THE DEVICE PRONGS WOULD NOT OPEN. THE HANDLE CANNULA WAS KINKED ON THE PROXIMAL SIDE OF THE HANDLE SPOOL. THE OUTER AND INNER SHEATHS, AS WELL AS, THE SUB-ASSEMBLY WERE ALSO KINKED. ALL OF THE PRONGS WERE PRESENT AND ATTACHED. PER THE EVENT INFORMATION, THE DEFECT WAS IDENTIFIED INSIDE THE PATIENT DURING THE PROCEDURE. MOST LIKELY, DUE TO SOME PROCEDURAL OR ANATOMICAL ASPECT, THE WORKING LENGTH AND WIRE SUB-ASSEMBLY BECAME KINKED. ATTEMPTS TO ACTUATE THE PRONGS WITH THE WIRE SUB-ASSEMBLY BOUND WITHIN THE SHEATHS MOST LIKELY CAUSED THE HANDLE CANNULA TO KINK; THIS WOULD NOT ALLOW THE PRONGS TO OPEN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. IT SHOULD ALSO BE NOTED THAT THE EVALUATION OF THE SUSPECT RETURNED DEVICE OF THE PRONGS NOT OPENING IS A NON-REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON STONE RETRIEVAL GRASPING FORCEPS WAS USED DURING A CYSTOSCOPY PROCEDURE. THERE WAS NO PATIENT INFORMATION REPORTED OR ABLE TO BE OBTAINED. ACCORDING TO THE COMPLAINANT, DURING A DIFFICULT PROCEDURE INVOLVING CHANGING THE RIGHT URETHRAL STENT, THE DEVICE MALFUNCTIONED IN THAT IT DID NOT DO WHAT IT WAS SUPPOSED TO DO. SEVERAL ATTEMPTS TO OBTAIN THE SPECIFICS OF WHAT WAS MEANT BY THIS FAILURE WERE NOT ABLE TO BE OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TALON STONE RETRIEVAL GRASPING FORCEPS WAS USED DURING A CYSTOSCOPY PROCEDURE. THERE WAS NO PATIENT INFORMATION REPORTED OR ABLE TO BE OBTAINED. ACCORDING TO THE COMPLAINANT, DURING A DIFFICULT PROCEDURE INVOLVING CHANGING THE RIGHT URETHRAL STENT, THE DEVICE MALFUNCTIONED IN THAT IT DID NOT DO WHAT IT WAS SUPPOSED TO DO. SEVERAL ATTEMPTS TO OBTAIN THE SPECIFICS OF WHAT WAS MEANT BY THIS FAILURE WERE NOT ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRICEP¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063701180 13224319

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR