BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2111933 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01893
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ONE OF THE PULL WIRES WAS DETACHED FROM THE TANG HOLE OF THE JAW. THE DEVICE WAS SENT FOR MATERIAL ANALYSIS WHICH DETERMINED THAT IT DID NOT PRESENT ANY MATERIAL ANOMALIES. FURTHERMORE IT WAS FOUND THAT THE Z-BEND OF THE DETACHED PULL WIRE WAS DEFORMED AND ELONGATED DUE TO TENSIONAL OVERLOAD FORCE, WHICH MOST LIKELY CAUSED IT TO DETACH FROM THE JAW. FUNCTIONALLY, THE JAWS OPENED UNEVENLY DUE TO THE DETACHED PULL WIRE, AND NO FURTHER FUNCTIONAL TESTING WAS PERFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE PULL WIRE WAS DISCONNECTED. EVALUATION OF THE RETURNED UNIT FOUND THAT ONE PULL WIRE HAD DETACHED FROM THE TANG HOLE OF THE JAW. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE, HOWEVER, AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE BATCH NUMBER, HOWEVER, THE DEVICE RETURNED WITH PACKAGING MATERIAL IDENTIFYING THE LOT NO. AS (B)(4). ADDITIONALLY, DURING THE EVALUATION, A SHIP HISTORY WAS PERFORMED WHICH REVEALED THIS TO BE THE ONLY LOT PROVIDED TO THE CUSTOMER. FURTHER CONFIRMATION RECEIVED INDICATING THAT THE PRODUCT RETURNED WAS THE COMPLAINT DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE BATCH NUMBER, HOWEVER THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION WITH PACKAGING MATERIAL INDICATING BATCH# 14125063, DEVICE EXPIRATION DATE 02/08/2014, AND DEVICE MANUFACTURED DATE 02/11/2011. IT IS UNKNOWN WHETHER THIS IS THE ACTUAL BATCH NUMBER OF THE DEVICE INVOLVED IN THE REPORTED EVENT. 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 4 PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOUR TO FIVE SUCCESSFUL PASSES WERE MADE THROUGH THE SCOPE WITH NO ISSUES. AFTER THE FIFTH OR SIXTH TIME IT WAS NOTICED THAT THE PULL-WIRE WAS DISCONNECTED AND THE JAWS WOULD NOT FUNCTION. REPORTEDLY, THE PULL WIRE REMAINED ATTACHED TO THE DEVICE AND DID NOT DISENGAGE INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOUR TO FIVE SUCCESSFUL PASSES WERE MADE THROUGH THE SCOPE WITH NO ISSUES. AFTER THE FIFTH OR SIXTH TIME IT WAS NOTICED THAT THE PULL-WIRE WAS DISCONNECTED AND THE JAWS WOULD NOT FUNCTION. REPORTEDLY, THE PULL WIRE REMAINED ATTACHED TO THE DEVICE AND DID NOT DISENGAGE INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOUR TO FIVE SUCCESSFUL PASSES WERE MADE THROUGH THE SCOPE WITH NO ISSUES. AFTER THE FIFTH OR SIXTH TIME IT WAS NOTICED THAT THE PULL-WIRE WAS DISCONNECTED AND THE JAWS WOULD NOT FUNCTION. REPORTEDLY, THE PULL WIRE REMAINED ATTACHED TO THE DEVICE AND DID NOT DISENGAGE INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515191 0014125063

    Patients

    Seq Age Sex Outcome Treatment
    1