BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS

    MDR report key: 1875003 · Received October 19, 2010

    Report

    Report Number
    3005099803-2010-04313
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EOQ
    PMA / PMN Number
    K895415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CATHETER CUT AND THE PULL-WIRES WERE DAMAGED. FUNCTIONALLY, THE RETURNED UNIT COULD NOT BE TESTED DUE TO THE SAMPLE RETURN CONDITION. DUE TO CONDITION OF THE RETURNED INCIDENT DEVICE NO FUNCTIONAL TESTING COULD BE PERFORMED, THEREFORE THE REPORTED CONDITION OF THE JAWS NOT CLOSING COULD NOT BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS ANATOMICAL OR PROCEDURAL FACTORS MAY HAVE LIMITED THE DEVICE PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER (B)(6) OLD. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING A RESPIRATORY BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TISSUE WAS SAMPLED THREE TIMES WITHOUT PROBLEM, HOWEVER, WHILE TAKING THE FOURTH BIOPSY SAMPLE THE JAWS COULD NOT BE CLOSED. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM, AND THE DEVICE WAS CUT TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH THIS RADIAL JAW 3 PULMONARY SINGLE-USE BIOPSY FORCEPS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING A RESPIRATORY BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TISSUE WAS SAMPLED THREE TIMES WITHOUT PROBLEM, HOWEVER, WHILE TAKING THE FOURTH BIOPSY SAMPLE THE JAWS COULD NOT BE CLOSED. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM, AND THE DEVICE WAS CUT TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH THIS RADIAL JAW 3 PULMONARY SINGLE-USE BIOPSY FORCEPS 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 BIOPSY FORCEPS BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - COSTA RICA M00515231 13209083

    Patients

    Seq Age Sex Outcome Treatment
    1