BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1830408 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03884
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CATHETER CUT ON BOTH DISTAL AND PROXIMAL ENDS. THE PROXIMAL END OF THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE COIL WAS DAMAGED NEAR THE DISTAL END. THE DISTAL SECTION COMPONENTS SUCH AS THE JAWS AND CLEVIS WERE VISUALLY INSPECTED AND WERE WITHIN SPECIFICATIONS. FURTHERMORE, THE DEVICE RIVETING AND WELDING WAS EXAMINED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED TO THE COMPLAINT DEVICE DUE TO THE CONDITION IT WAS RECEIVED. 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 UNDETERMINABLE. 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

    (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)

    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 PEG INSERTION PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE FORCEPS WOULD NOT CLOSE. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM AND THE FORCEPS CATHETER WAS CUT TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY NO DAMAGE WAS NOTED TO THE DEVICE AND IT WAS NOT INSPECTED/TESTED PRIOR TO USE. 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 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A PEG INSERTION PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE FORCEPS WOULD NOT CLOSE. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM AND THE FORCEPS CATHETER WAS CUT TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY NO DAMAGE WAS NOTED TO THE DEVICE AND IT WAS NOT INSPECTED/TESTED PRIOR TO USE. 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 M00515342 0013380501

    Patients

    Seq Age Sex Outcome Treatment
    1