BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP BALL ELECTRODES

    MDR report key: 6805731 · Received August 18, 2017

    Report

    Report Number
    1216677-2017-00057
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Report Date
    October 3, 2017
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K905747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT-(B)(4). 10/3/2017 UPDATE: INVESTIGATION: ANALYSIS AND FINDINGS: THE ROOT CAUSE OF THE REPORTED EVENT THAT THE "DR COULD NOT GET THE B0512 BALL ELECTRODE IN THE OLSEN 950 HAND PIECE" CANNOT BE VERIFIED, AND IS CONSIDERED INDETERMINABLE AS THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE CONDITION, OR STATE OF THE OLSON 950 HAND PIECE COULD NOT BE DETERMINED. HOWEVER, IF THE AFFECTED DEVICE IS RETURNED IN THE FUTURE AND MADE AVAILABLE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. THE PROCESS OF MANUFACTURING THE BALL ELECTRODE ENSURES THAT EACH ELECTRODE IS FREE OF ANY DAMAGE AND IS CONFORMING AS PER IN-PROCESS WORK INSTRUCTIONS. ALTHOUGH INDETERMINABLE, IT'S POSSIBLE THAT THE ELECTRODE MAY HAVE BEEN DAMAGED AFTER IT WAS SHIPPED FROM THE CSI FG (B)(4) WAREHOUSE. A REVIEW OF THE LOT DHR INDICATED IT WAS MANUFACTURED TWO YEARS PRIOR TO THE REPORTED EVENT. THE DHR DID NOT REVEAL ANY ABNORMALITY. CORRECTIVE ACTIONS: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME AS THE AFFECTED DEVICE WAS NOT RETURNED PER SCRAP RMA # (B)(4). A REVIEW OF THE MANUFACTURING PROCESS DID NOT REVEAL ANY CHANGES AND SHOWED IT TO BE STABLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. REASON: PER (B)(4), THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "DR (B)(6) COULD NOT GET THE B0512 IN THE OLSEN 950 HAND PIECE. LOT NUMBER IS 173808. ALL DISPOSED OF AT SITE. THE PATIENT BLED HEAVILY UNTIL HE COULD STOP WITH LUGOLS. THE PATIENT IS OK." REFERENCE E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    "DR (B)(6) COULD NOT GET THE B0512 IN THE OLSEN 950 HAND PIECE. LOT NUMBER IS 173808. ALL DISPOSED OF AT SITE. THE PATIENT BLED HEAVILY UNTIL HE COULD STOP WITH LUGOLS. THE PATIENT IS OK." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586058 LEEP BALL ELECTRODES LEEP BALL ELECTRODES HGI COOPERSURGICAL, INC. B0512 173808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention