BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 1982441 · Received February 9, 2011

    Report

    Report Number
    3005099803-2011-00309
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 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 OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. SIMILARLY, THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATIONS. CURRENT RESISTANCE TESTING FOUND NO ANOMALIES EITHER. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT SINCE AFTER ELECTRICALLY TESTING THE RETURNED UNIT IT WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. SINCE A SPECIFIC CAUSE OF THE REPORTED FAILURE CANNOT BE IDENTIFIED, A MOST PROBABLE ROOT CAUSE IS 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):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 3 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PERFORMED AN EXCISION OF A LARGE INTESTINE TUMOR (TUMOR SIZE: ABOUT 2MM, COAGULATION WAVE: 30W), THE ABLATION WAS NOT COMPLETED. NO DEVICE DAMAGE WAS NOTED/REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS DEVICE WITH THE SAME ACTIVE CORD. REPORTEDLY THE DEVICE WAS NOT INSPECTED/TESTED 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 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PERFORMED AN EXCISION OF A LARGE INTESTINE TUMOR (TUMOR SIZE: ABOUT 2MM, COAGULATION WAVE: 30W), THE ABLATION WAS NOT COMPLETED. NO DEVICE DAMAGE WAS NOTED/REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS DEVICE WITH THE SAME ACTIVE CORD. REPORTEDLY THE DEVICE WAS NOT INSPECTED/TESTED 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 0013699978

    Patients

    Seq Age Sex Outcome Treatment
    1