BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1951274 · Received January 6, 2011

    Report

    Report Number
    3005099803-2010-05432
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 15, 2010
    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 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATION. SIMILARLY, THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATION; THE JAWS OPENED AND CLOSED WITHOUT ISSUE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE JAWS FAILED TO CLOSE PROPERLY. THE EVALUATION FOUND THAT THE DEVICE WAS WITHIN MANUFACTURING SPECIFICATION. THEREFORE, THE COMPLAINT WAS NOT CONFIRMED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGEAL BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE THROUGH THE WORKING CHANNEL, THE FORCEPS WAS PARTIALLY OPENED. HOWEVER, THE JAWS WERE NOT ABLE TO BE FULLY CLOSED. THE FORCEPS WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO BEGINNING THE PROCEDURE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGEAL BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE THROUGH THE WORKING CHANNEL, THE FORCEPS WAS PARTIALLY OPENED. HOWEVER, THE JAWS WERE NOT ABLE TO BE FULLY CLOSED. THE FORCEPS WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE OR PACKAGING PRIOR TO BEGINNING THE PROCEDURE. 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 STABLE.

    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 UNK355

    Patients

    Seq Age Sex Outcome Treatment
    1