BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2190174 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02650
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE OVER THE AGE OF 18 YEARS 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ONE PULLWIRE WAS BROKEN. FUNCTIONALLY, THE UNIT WAS NOT TESTED DUE TO THE RETURN CONDITION. FURTHER ANALYSIS OF THE BROKEN PULLWIRE DETERMINED THAT THE FRACTURE OCCURRED DUE TO FATIGUE FROM A BENDING CYCLIC OVERLOAD. NO MATERIAL ANOMALIES WERE NOTED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE PULLWIRE FAILED. THE EVALUATION CONFIRMED THAT THE BROKEN PULLWIRE HAD NO MATERIAL ANOMALIES. ADDITIONALLY, THE USER REPORTED THAT THE FORCEPS DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE OBSERVED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE BREAK LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE DUAL PULL WIRES FAILED. REPORTEDLY NO COMPLICATIONS WERE ENCOUNTERED WHEN REMOVING THIS DEVICE AND NO BIOPSIES WERE RETRIEVED WITH THIS DEVICE. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE DUAL PULL WIRES FAILED. REPORTEDLY NO COMPLICATIONS WERE ENCOUNTERED WHEN REMOVING THIS DEVICE AND NO BIOPSIES WERE RETRIEVED WITH THIS DEVICE. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513402 0014149668

    Patients

    Seq Age Sex Outcome Treatment
    1