BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 2062850 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01271
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 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: GENERATOR: (B)(4) (ERBE). 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. (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 DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE THROUGH THE SCOPE, AN ATTEMPT WAS MADE TO APPLY ELECTRIC CURRENT. HOWEVER, THE FORCEPS FAILED TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THE ACTIVE CORD USED IN THE PROCEDURE WAS NOT A BSC DEVICE. THE SAME ACTIVE CORD WAS USED TO COMPLETE THE PROCEDURE.

    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