BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1832592 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03894
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. PATIENT AGE IS UNKNOWN, HOWEVER REPORTED TO BE OVER 18 YEARS OLD. THE DEVICE HAS BEEN RECEIVED FRO 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 THE JAWS/CUPS IN AN "L" SHAPE AND THE NEEDLE TAIL WAS BENT OUT OF THE CLEVIS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN AND CLOSE NORMALLY CONSIDERING THE BENT NEEDLE TAIL. THE CURVES WERE MEASURED AND BOTH WERE OUT OF SPECIFICATION AND COULD HAVE CAUSED THE BENDING OF THE NEEDLE TAIL. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; WIRE PROTRUDING. HOWEVER, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. THERE IS AN INVESTIGATION IN PROGRESS TO DETERMINE THE ROOT CAUSE OF CURVING ISSUES. 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).

    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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PULL WIRE WAS EXPOSED. THE PULL WIRE APPEARED TO BREAK AT A LATERAL ANGLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NOT PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PULL WIRE WAS EXPOSED. THE PULL WIRE APPEARED TO BREAK AT A LATERAL ANGLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NOT PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515370 12976790

    Patients

    Seq Age Sex Outcome Treatment
    1