BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1970254 · Received January 25, 2011

    Report

    Report Number
    3005099803-2011-00107
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (JAWS WON'T CLOSE).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)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE NEEDLE BENT. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN HOWEVER, THE BENT NEEDLE DID NOT ALLOW PROPER JAW CLOSURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE CONFIRMS THE REPORTED CONDITION, SINCE THE OBSERVED DAMAGE PREVENTS THE DEVICE FROM CLOSING PROPERLY. 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 DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFERENCE MANUFACTURER REPORT # 3005099803-2011-00107, 3005099803-2011-00108, AND 3005099803-2011-00109 FOR THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS OF THREE FORCEPS DEVICES WOULD NOT CLOSE WHILE INSIDE THE PATIENT. IN EACH CASE THE PHYSICIAN WAS ABLE TO REMOVE THE FORCEPS WITH NO DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH A FOURTH 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFERENCE MANUFACTURER REPORT # 3005099803-2011-00107, 3005099803-2011-00108, AND 3005099803-2011-00109 FOR THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS OF THREE FORCEPS DEVICES WOULD NOT CLOSE WHILE INSIDE THE PATIENT. IN EACH CASE THE PHYSICIAN WAS ABLE TO REMOVE THE FORCEPS WITH NO DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH A FOURTH 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 FINE.

    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 M00515373 0013878347

    Patients

    Seq Age Sex Outcome Treatment
    1