BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOSNARE

    MDR report key: 1823873 · Received September 2, 2010

    Report

    Report Number
    3005099803-2010-03624
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    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

    THE RETURNED DEVICE PRESENTED WITH THE CAUTERY PIN DETACHED FROM THE DEVICE. MEASUREMENTS TAKEN OF THE PIN WERE FOUND TO BE WITHIN SPECIFICATION. FUNCTIONAL TESTING SHOWED THAT THE DEVICE RETRACTED AND EXTENDED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CAUTERY PIN SEPARATED FROM THE DEVICE. BASED ON THE EVALUATION, IMPROPER ASSEMBLY OF THE CAUTERY PIN LIKELY LED TO DETACHMENT. FURTHER REVIEW OF THIS ISSUE IS ONGOING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE METAL PARTS OF THE ACTIVE CODE CONNECTOR", ALSO KNOWN AS THE CAUTERY PIN, SEPARATED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION 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 A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE METAL PARTS OF THE ACTIVE CODE CONNECTOR", ALSO KNOWN AS THE CAUTERY PIN, SEPARATED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOSNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561821 0013013607

    Patients

    Seq Age Sex Outcome Treatment
    1