BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD-OPTIMIZER POLYPECTOMY SNARE

    MDR report key: 1066286 · Received June 26, 2008

    Report

    Report Number
    9710641-2008-00083
    Event Type
    Other
    Date Received
    June 26, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BARD ENDO TECHNOLOGIES
    Product Code
    FDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED AND IS BEING EVALUATED BY THE QE. THIS DEVICE WAS MFG BY BARD ENDOSCOPIC TECHNOLOGIES PRIOR TO THE ACQUISITION OF BARD BY CONMED CORP IN 09/2004. WE ARE UNABLE TO DETERMINE THE MEANING OF THE LOT CODE; HOWEVER, THE DEVICE HAS A 36 MO SHELF LIFE. IT WOULD HAVE EXPIRED PRIOR TO 12/31/2007. HENCE AN EXPIRED DEVICE WAS USED FOR THIS PROCEDURE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ENGINEER'S REPORT IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING COLONOSCOPY", A LARGE SNARE WAS USED TO REMOVE A POLYP. THE SNARE PRODUCED NO BURN. THERE WAS CORRECT GROUNDING, ACTIVE CORD AND PROPER ATTACHMENTS TO THE SNARE. THE SNARE WAS UNABLE TO BE REMOVED FROM THE POLYP, USING MULTIPLE MANEUVERS BY THE PHYSICIAN. THE SNARE WAS CUT, LEFT TAPED TO THE PT, AND THE PT WAS SENT TO (B) (6) HOSPITAL FOR REMOVAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD-OPTIMIZER POLYPECTOMY SNARE POLYPECTOMY SNARE FDI BARD ENDO TECHNOLOGIES NA REPG0429

    Patients

    Seq Age Sex Outcome Treatment
    1