BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2507704 · Received March 28, 2012

    Report

    Report Number
    3005099803-2012-01087
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT EVENT DATE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PROCEDURE TOOK PLACE SOMETIME DURING THE WEEK OF (B)(6) 2012 CONCOMITANT MEDICAL PRODUCT - OLYMPUS ACTIVE CORD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CAPTURED THE POLYP AT ITS BASE WITH THE FORCEPS. THE FORCEPS STARTED TO CAUTERIZE, HOWEVER, THE ENTIRE FORCEPS DID NOT GET HOT. THE PROXIMAL END OF THE FORCEPS DID NOT HEAT UP, AND THE TIP OF THE POLYP BEGAN TO BLEED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND EPINEPHRINE WAS INJECTED TO STOP THE BLEED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. REPORTEDLY, THERE WAS NO VISIBLE DAMAGE NOTED WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 14426069

    Patients

    Seq Age Sex Outcome Treatment
    1