BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2022304 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00788
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 25, 2011
    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):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 THAT THE WASHER TAIL WAS BENT OUT OF THE CLEVIS. ADDITIONALLY, NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATION. THE DEVICE OPENED AND CLOSED WITHIN SPECIFICATION DESPITE THE WASHER TAIL BEING BENT OUT OF THE CLEVIS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT. THE EVALUATION FOUND THAT THE PULL WIRE WAS NOT BROKEN, BUT THE WASHER TAIL WAS BENT AND APPEARED AS IF A WIRE WAS BROKEN. THE FORCEPS ARE DESIGNED TO COLLECT TISSUES ENDOSCOPICALLY. THE DEVICE WAS USED IN A BRONCHOSCOPY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITING THE DEVICE'S PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER TAKING A BIOPSY IT WAS NOTED THAT ONE PULL WIRE WAS BROKEN AT THE TIP OF THE FORCEPS. NO PART OF THE WIRE DETACHED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ADDITIONALLY IT WAS REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 4 BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER TAKING A BIOPSY IT WAS NOTED THAT ONE PULL WIRE WAS BROKEN AT THE TIP OF THE FORCEPS. NO PART OF THE WIRE DETACHED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ADDITIONALLY IT WAS REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513301 13937100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR