BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿

    MDR report key: 2213070 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02768
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EOQ
    PMA / PMN Number
    K895415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. FUNCTIONALLY, THE JAWS WERE ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE WITHDRAWING THE DEVICE FROM THE ENDOSCOPE, THE JAWS COULD NOT BE CLOSED. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: NO DEVICE DAMAGE OR ANOMALIES WERE NOTED. ADDITIONALLY, BIOPSIES HAD BEEN COLLECTED WITH THIS DEVICE PRIOR TO THE ALLEGED FAILURE. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW PULMONARY SINGLE-USE BIOPSY FORCEPS DEVICE. FURTHERMORE, NO DIFFICULTY OR RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE DEVICE FROM THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - COSTA RICA M00512661 13938136

    Patients

    Seq Age Sex Outcome Treatment
    1