BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 2173537 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02474
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCT: ERBE GENERATOR ICC-200. 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 NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING. THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATIONS. SIMILARLY, A RESISTANCE TEST WAS ALSO PERFORMED AND THE UNIT MEASURED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT; FAILURE TO DELIVER ENERGY. THE COMPLAINT WAS NOT CONFIRMED. 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 BIOPSY FORCEPS WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS POSITIONED AT THE DESIRED LOCATION, WITHIN THE PATIENT'S LARGE INTESTINE. WHEN ELECTRIC CURRENT WAS APPLIED THE DEVICE FAILED TO DELIVER ENERGY AND WOULD NOT CAUTERIZE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE AND THE SAME NON-BSC ACTIVE CORD. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS NOT TESTED AND INSPECTED PRIOR TO USE. 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 GOOD

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS POSITIONED AT THE DESIRED LOCATION, WITHIN THE PATIENT'S LARGE INTESTINE. WHEN ELECTRIC CURRENT WAS APPLIED THE DEVICE FAILED TO DELIVER ENERGY AND WOULD NOT CAUTERIZE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE AND THE SAME NON-BSC ACTIVE CORD. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS NOT TESTED AND INSPECTED PRIOR TO USE. 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 GOOD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515501 0013410067

    Patients

    Seq Age Sex Outcome Treatment
    1