BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2223608 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02936
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CAUTERY PIN WAS MISSING FROM THE HANDLE. THE LOOP EXTENDED AND RETRACTED ACCORDING TO SPECIFICATIONS DURING FUNCTIONAL TESTING. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CAUTERY PIN DETACHED; THE COMPLAINT WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT IS A MANUFACTURING ISSUE, AND AN INVESTIGATION HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. IT WAS CONFIRMED THAT THIS LOT WAS MANUFACTURED PRIOR TO THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE CAUTERY PIN WAS NOTED TO BE DETACHED WHEN THE DEVICE WAS CONNECTED TO THE GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE CAUTERY PIN WAS NOTED TO BE DETACHED WHEN THE DEVICE WAS CONNECTED TO THE GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561821 12797085

    Patients

    Seq Age Sex Outcome Treatment
    1