BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR RF SAPHYRE

    MDR report key: 2464643 · Received February 22, 2012

    Report

    Report Number
    3003604053-2012-00008
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 26, 2012
    Manufacturer
    SMITH & NEPHEW ANDOVER MANUFACTURING SITE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW (B)(4) SENT THE DEVICE OUT FOR EVALUATION TO AN UNAUTHORIZED FACILITY. THE RESULTS OF (B)(4)'S INVESTIGATION DO NOT COINCIDE WITH INVESTIGATION RESULTS OF OUR SUPPLIER (B)(4). (B)(4)'S EVALUATION RESULTS WERE THEN SENT TO OUR SUPPLIER ((B)(4)) FOR EVALUATION. THE SUPPLIER'S INVESTIGATION CONSIDERS THIS ISSUE TO BE CAUSED BY A WEAK JOINING OF THE PLATE (ELECTRODE) TO THE SHAFT DURING THE MANUFACTURING PROCESS. THE SUPPLIER EXPLANATION PROVIDED INDICATES AN EXCESSIVE GAP BETWEEN THE ELECTRODE TIP AND THE PTFE TUBE. CORRECTIVE ACTION HAS TAKEN PLACE AT OUR SUPPLIER AND OPERATOR RETRAINING WAS CONDUCTED AT THE VENDOR. THE EXISTING INVENTORY OF THE COMPONENT WITHIN OUR SUPPLIER'S CONTROL WAS 100% INSPECTED. THE LOT IDENTIFIED IN THE COMPLAINT WAS MADE PRIOR TO THE CORRECTIVE ACTION. A COMPLAINT REVIEW HAS BEEN COMPLETED ON THE SAPHYRE PROBE PART NUMBER 7209686 AND SHOWS NO OTHER COMPLAINTS ISSUED FOR THIS DEFECT. OUR SUPPLIER AND SMITH & NEPHEW WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    AFTER THE PROCEDURE WAS COMPLETED THEY FOUND THE DEVICE WAS BROKEN AND THE TIP WAS MISSING. THE MISSING TIP WAS NOT FOUND IN THE SURROUNDING AREA AND AN X-RAY CONFIRMED THAT IT REMAINED IN THE PATIENT. THE DEVICE WILL NOT BE SHIPPED TO OUR (B)(6) FACILITY UNTIL (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR RF SAPHYRE PROBE,SAPHYRE 90DEG GEI SMITH & NEPHEW ANDOVER MANUFACTURING SITE 7209686 1017060

    Patients

    Seq Age Sex Outcome Treatment
    1