BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1884105 · Received October 27, 2010

    Report

    Report Number
    3005099803-2010-04517
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WASHER TAIL WAS BENT OUT OF THE CLEVIS. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN AND CLOSE NORMALLY CONSIDERING THE BENT WASHER TAIL. MEASUREMENTS WERE TAKEN OF THE PULL WIRE CURVES AND IT WAS DETERMINED THAT ONE WAS OUT OF SPECIFICATION AND COULD HAVE CAUSED THE BENDING OF THE WASHER TAIL. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; WIRE PROTRUDING. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED. THEREFORE THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE, HOWEVER, AN INVESTIGATION IS UNDERWAY 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES 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 4 SINGLE USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT A WIRE WAS PROTRUDING NEAR THE CUP OF THE FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT A WIRE WAS PROTRUDING NEAR THE CUP OF THE FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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 M00513321 13651171

    Patients

    Seq Age Sex Outcome Treatment
    1