BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2013266 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00690
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) :THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    A BIOPSY OF THE TERMINAL ILEUM WAS TO BE PERFORMED. HOWEVER, THE FORCEPS JAWS FAILED TO CLOSE PROPERLY. NO BIOPSY SPECIMEN WAS RETRIEVED PRIOR TO THIS FAILURE. ADDITIONALLY, THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE FIRST PASS IN THE PATIENT, THE BIOPSY FORCEPS FAILED TO CLOSE PROPERLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513331 0013605470

    Patients

    Seq Age Sex Outcome Treatment
    1