BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 1920273 · Received December 10, 2010

    Report

    Report Number
    3005099803-2010-05075
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT A GENERATOR ERROR (H07) OCCURRED. DURING THE EVALUATION, AN OPEN FUSE F3 AND FAULTY SOLDER JOINTS WERE IDENTIFIED, WHICH LIKELY CONTRIBUTED TO THE EVENT. THE MOST PROBABLE ROOT CAUSE, CONSIDERING AGE AND USAGE OF THE DEVICE, IS WEAR AND TEAR. 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 SERIAL NUMBER. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS TO BE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE ABLATION, THE GENERATOR WAS POWERED ON, BUT AN ERROR (H07) OCCURRED AND WAS NOT ABLE TO BE CLEARED. 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 OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS TO BE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE ABLATION, THE GENERATOR WAS POWERED ON, BUT AN ERROR (H07) OCCURRED AND WAS NOT ABLE TO BE CLEARED. 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M00126221R0

    Patients

    Seq Age Sex Outcome Treatment
    1