BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2318708 · Received November 2, 2011

    Report

    Report Number
    3005099803-2011-03722
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - PSD-60 (OLYMPUS), OLYMPUS ACTIVE CORD. THE COMPLAINANT INDICATED THAT THE DEVICE 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 BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AN ATTEMPT WAS MADE TO RETRIEVE A MUCOSAL BIOPSY FROM THE STOMACH, HOWEVER THE TISSUE WAS NOT COAGULATED FULLY. THE SETTING VALUE OF THE HIGH-FREQUENCY EQUIPMENT WAS CHANGED FROM 30W TO 50W BUT THE PROBLEM WAS NOT RESOLVED. NO BIOPSIES WERE RETRIEVED WITH THIS DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515031 13881642

    Patients

    Seq Age Sex Outcome Treatment
    1