BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2439813 · Received February 6, 2012

    Report

    Report Number
    3005099803-2012-00433
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A POLYP WAS REMOVED WITH THIS FORCEPS DEVICE. A BLEED OCCURRED AT THE BIOPSY SITE WHICH WAS TREATED USING A RESOLUTION CLIP. REPORTEDLY, THE BITE TAKEN BY THE DEVICE WAS LARGER THAN WHAT THE USER WAS ACCUSTOMED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00515033

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention