BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2173426 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02475
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WASHER TAIL WAS BENT. FUNCTIONALLY, THE JAWS OPENED AND CLOSED WITHOUT ISSUE. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT. HOWEVER, THE EVALUATION FOUND THAT THE WASHER TAIL WAS BENT, WHICH THE CUSTOMER LIKELY ASSOCIATED WITH THE PULLWIRE. THE BEND LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. 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 BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, FOUR BIOPSIES WERE SUCCESSFULLY OBTAINED WITH THIS DEVICE; TWO FROM THE STOMACH AND TWO FROM THE ESOPHAGUS. HOWEVER, WHILE ATTEMPTING TO TAKE A BIOPSY IN THE DUODENUM, ONE OF THE PULLWIRES WAS FOUND TO BE BROKE AND THE DEVICE NO LONGER FUNCTIONED PROPERLY. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM, THEN THE FORCEPS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS DEVICE. REPORTEDLY, THE DEVICE WAS INSPECTED/TESTED 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, FOUR BIOPSIES WERE SUCCESSFULLY OBTAINED WITH THIS DEVICE; TWO FROM THE STOMACH AND TWO FROM THE ESOPHAGUS. HOWEVER, WHILE ATTEMPTING TO TAKE A BIOPSY IN THE DUODENUM, ONE OF THE PULLWIRES WAS FOUND TO BE BROKE AND THE DEVICE NO LONGER FUNCTIONED PROPERLY. THE DEVICE AND SCOPE WERE REMOVED FROM THE PATIENT IN TANDEM, THEN THE FORCEPS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS DEVICE. REPORTEDLY, THE DEVICE WAS INSPECTED/TESTED 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 3 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515981 0014201028

    Patients

    Seq Age Sex Outcome Treatment
    1