BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 2954201 · Received January 29, 2007

    Report

    Report Number
    6000150-2007-00010
    Event Type
    Injury
    Date Received
    January 29, 2007
    Date of Event
    November 2, 2006
    Report Date
    November 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    KNS
    PMA / PMN Number
    K810336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: LOOP WIRE, BROKE. (B)(4). EVAL: THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC (BSC) ON (B)(4) 2006. A VISUAL EXAM OF THE RETURNED DEVICE WAS PERFORMED. DURING EXAM IT WAS OBSERVED THAT THE WIRE WAS BROKEN AND SEEMED TO BE BURNED. SINCE THE WIRE WAS BROKEN FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE, LOT 8526198 MEETS ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE RETURNED DEVICE IS CONFIRMED; HOWEVER THERE IS NO EVIDENCE TO DETERMINE THE CAUSE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED TO BOSTON SCIENTIFIC (BSC) ON 2006 THAT A PT UNDERWENT A THERAPEUTIC PROCEDURE. THE SENSATION JUMBO SNARE WAS UTILIZED DURING THE PROCEDURE WHEN THE 'WIRE BROKE CAUSING POTENTIAL CUTTING ACTION AND TRAUMA TO THE PTS ANATOMY.' AT THE TIME OF THE INITIAL REPORT, THE CUSTOMER INDICATED THAT THE SUBJECT DEVICE WAS REPROCESSED AND REUSED. SUBSEQUENT F/U INFO ON (B)(6) 2007, PROVIDED BY THE CUSTOMER REVEALED THAT THE SUBJECT DEVICE HAD NOT BEEN REPROCESSED. BSC IS NOT AWARE OF ANY ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYPECTOMY SNARE KNS BOSTON SCIENTIFIC CORP M00565651 8526198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK