BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1813595 · Received August 25, 2010

    Report

    Report Number
    3005099803-2010-03634
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    March 5, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (JAWS WON'T CLOSE). (B)(4): 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 VISUAL ANOMALIES. FUNCTIONALLY THE RETURNED UNIT WOULD CLOSE CORRECTLY, HOWEVER UPON HANDLE ACTUATION THE TWO JAWS DID NOT OPEN SIMULTANEOUSLY. ONE JAW OPEN FIRST AND THEN THE OTHER JAW WOULD OPEN. MEASUREMENTS WERE TAKEN OF THE WIRE CURVES AND IT WAS DETERMINED THAT ONE WAS OUT OF SPECIFICATION AND COULD HAVE CAUSED THE IMPROPER JAW OPENING. THE COMPLAINT 'UNABLE TO CLOSE CORRECTLY' WAS NOT CONFIRMED SINCE THE UNIT CLOSED ACCORDING TO SPECIFICATIONS. HOWEVER, THE COMPLAINT 'UNABLE TO OPEN CORRECTLY' WAS CONFIRMED SINCE ONE WIRE CURVE WAS FOUND OUT OF SPECIFICATION CAUSING THE UNIT TO NOT OPEN PROPERLY. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. FURTHERMORE, THERE ARE CURRENT CONTROLS IN THE MANUFACTURING PROCESS TO ASSURE PRODUCT INTEGRITY AND AVOID PRODUCT PERFORMANCE ISSUES. 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. BASED ON THE COMPLAINT DEVICE EVALUATION RESULTS, THE JAWS OF THE DEVICE WOULD CLOSE CORRECTLY, THEREFORE THIS REPORT IS NO LONGER CONSIDERED AN MDR REPORTABLE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OPEN AND CLOSE CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OPEN AND CLOSE CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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. 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515362 13079448

    Patients

    Seq Age Sex Outcome Treatment
    1