BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 HOT BIOPSY FORCEPS

    MDR report key: 2153401 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-01999
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MANUFACTURE DATE CANNOT BE DETERMINED. THE RETURNED DEVICE WAS RECEIVED CUT WITHOUT THE PROXIMAL SECTION OF THE CATHETER; ONLY THE CLEVIS-CUTTER SUBASSEMBLY WAS RECEIVED. A VISUAL EXAMINATION OF THE RETURNED SEGMENT DID NOT REVEAL ANY ANOMALIES. THE CAUSE OF THE DETACHED COMPONENT COULD NOT BE DETERMINED. THE (B)(6) 2008, 15-MONTH RADIAL JAW 3 HOT BIOPSY FORCEPS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008 THAT A RADIAL JAW 3 HOT BIOPSY FORCEPS DEVICE WAS USED FOR A COLONOSCOPY PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE FORCEPS WERE ADVANCED DOWN THE SCOPE AND THE HEAD OF THE FORCEPS DETACHED FROM THE CATHETER. THE HEAD OF THE FORCEPS REMAINED IN THE WORKING CHANNEL OF THE SCOPE, AND THE SCOPE WAS SENT OUT FOR REPAIR." IT WAS FURTHER REPORTED THAT A SECOND RADIAL JAW 3 HOT BIOPSY FORCEPS DEVICE WAS USED TO COMPLETE THE CASE, WITH NO COMPLICATIONS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 HOT BIOPSY FORCEPS KGE BOSTON SCIENTIFIC CORPORATION M00515503 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR