BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS

    MDR report key: 2495430 · Received March 19, 2012

    Report

    Report Number
    3005099803-2012-00721
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 FOUND THAT THE DEVICE WAS RETURNED WITH THE CAUTERY PLUG DETACHED FROM THE HANDLE. THE JAWS WERE NOT DETACHED. FUNCTIONALLY, THE JAWS OPENED AND CLOSED WITHIN SPECIFICATION. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE RETURNED DEVICE VISUALLY REFLECTS THE REPORTED ISSUE. BASED ON THE EVALUATION, THE ''GOLD TEETH'' DID NOT FALL OFF, HOWEVER, THE GOLD CAUTERY PIN WAS DETACHED FROM THE HANDLE. THE EVALUATION ATTRIBUTED THIS TO IMPROPER ASSEMBLY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 HOT BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE TESTING THE DEVICE, OUTSIDE THE PATIENT AND PRIOR TO USE, THE "GOLD TEETH" FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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 HOT BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE TESTING THE DEVICE, OUTSIDE THE PATIENT AND PRIOR TO USE, THE " GOLD TEETH" FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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 HOT SINGLE-USE BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00515500 14762073

    Patients

    Seq Age Sex Outcome Treatment
    1