BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 2191923 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02682
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 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

    A VISUAL EXAMINATION FOUND THE RETURN UNIT TO BE WITHIN SPECIFICATION. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING OR WELDING. FUNCTIONALLY, THE UNIT WAS ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. ADDITIONALLY, A RESISTANCE TEST WAS PERFORMED AND THE UNIT MET SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT 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.

    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 POLYPECTOMY PROCEDURE IN THE SIGMOID COLON PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE HOT BIOPSY FORCEPS WAS ADVANCED THROUGH THE SCOPE, AND AN ATTEMPT WAS MADE TO ABLATE A RESIDUAL POLYP. HOWEVER, WHEN ELECTRIC CURRENT WAS APPLIED, THE FORCEPS FAILED TO DELIVER ENERGY. AT THIS TIME, THE SNARE, WHICH WAS USED EARLIER IN THE CASE, WAS TESTED AND WORKED PROPERLY. THEREFORE, A SECOND ABLATION ATTEMPT WAS MADE WITH THE FORCEPS DEVICE, BUT THE SAME ISSUE RECURRED; NO ENERGY WAS DELIVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT 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 GOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515501 14235139

    Patients

    Seq Age Sex Outcome Treatment
    1