BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 2221047 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02901
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    March 21, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE TANG HOLE OF A JAW WAS BROKEN. THE DUAL PULL WIRES WERE INTACT AND NOT BROKEN AS REPORTED. THE BROKEN JAW WAS SENT FOR MATERIAL ANALYSIS WHICH REVEALED THAT THE FRACTURE SURFACE EXHIBITED A MATERIAL COLD FLOW MOLDING DEFECT. THIS CONDITION REFLECTS AN OCCURRENCE OF ARRESTED MATERIAL DURING THE SOLIDIFICATION PROCESS. THE DEVICE WELDING AND RIVETING WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE BROKEN JAW. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT SINCE THE PULL WIRES WERE INTACT AND NOT BROKEN. HOWEVER, THE FORCEPS RETURNED WITH ONE OF THE JAWS BROKEN AT THE TANG HOLE. MATERIAL ANALYSIS OF THE FRACTURED JAW REVEALED THAT THE FAILURE WAS DUE TO MATERIAL COLD FLOW AT THE SOLIDIFICATION PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. THERE IS AN OPEN SUPPLIER CORRECTIVE ACTION TO ADDRESS THIS ISSUE. 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

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. 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 TO BE USED DURING AN EDA PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTED THAT THE STEEL CABLE THAT KEEPS IT OPEN WAS BROKEN. NO FURTHER CLARIFICATION/INFORMATION COULD BE PROVIDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE 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 3 SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING AN EDA PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTED THAT THE STEEL CABLE THAT KEEPS IT OPEN WAS BROKEN. NO FURTHER CLARIFICATION/INFORMATION COULD BE PROVIDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515350 13651167

    Patients

    Seq Age Sex Outcome Treatment
    1