BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 5836970 · Received August 1, 2016

    Report

    Report Number
    3005099803-2016-02247
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE LOOP WAS BROKEN WITH EVIDENCE OF BURNING. THE COMPLAINT WAS CONFIRMED; DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING AN EMR PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE LOOP OF THE DEVICE BROKE INSIDE THE PATIENT WHEN THE OPERATOR ATTEMPTED TO APPLY CAUTERY TO THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS AT THE CONCLUSION OF THIS PROCEDURE AND THE PATIENT WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING AN EMR PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE LOOP OF THE DEVICE BROKE INSIDE THE PATIENT WHEN THE OPERATOR ATTEMPTED TO APPLY CAUTERY TO THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS AT THE CONCLUSION OF THIS PROCEDURE AND THE PATIENT WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488748 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 0018834652

    Patients

    Seq Age Sex Outcome Treatment
    1