BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL BASKET

    MDR report key: 2103580 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01793
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE EVENT OCCURRED PRIOR TO STONE RETRIEVAL. IT IS ALSO NOTED THAT A BASKET NOT OPENING OR CLOSING PRIOR TO STONE RETRIEVAL IS NOT A MEDWATCH REPORTABLE CONDITION.

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE SECOND OF FOUR DEVICES. REF: 3005099803-2011-01795, 3005099803-2011-01797, AND 3005099803-2011-01798. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS OPENED FOR USE IN A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE AND FOUND TO OPEN AND CLOSE WITHOUT PROBLEM. AFTER THE BASKET WAS PUT INTO THE SEMI-RIGID SCOPE IT FAILED TO OPEN AND CLOSE CORRECTLY. THE SCRUB NURSE SAID THAT BASKET HANDLE WAS NOT WORKING CORRECTLY AND BASKET DID NOT OPEN OR CLOSE PROPERLY AFTER GOING THROUGH SCOPE. FOUR GEMINI BASKETS WERE REPORTED TO HAVE THE SAME PROBLEM DURING THE SAME CASE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT IS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE SECOND OF FOUR DEVICES. REF: 3005099803-2011-01795, 3005099803-2011-01797, AND 3005099803-2011-01798. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS OPENED FOR USE IN A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE AND FOUND TO OPEN AND CLOSE WITHOUT PROBLEM. AFTER THE BASKET WAS PUT INTO THE SEMI-RIGID SCOPE IT FAILED TO OPEN AND CLOSE CORRECTLY. THE SCRUB NURSE SAID THAT BASKET HANDLE WAS NOT WORKING CORRECTLY AND BASKET DID NOT OPEN OR CLOSE PROPERLY AFTER GOING THROUGH SCOPE. FOUR GEMINI BASKETS WERE REPORTED TO HAVE THE SAME PROBLEM DURING THE SAME CASE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063303060 13601207

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR