BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPENCER PROBE ELECTRODES

    MDR report key: 8571114 · Received May 1, 2019

    Report

    Report Number
    2183456-2019-00002
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    February 8, 2018
    Report Date
    April 1, 2019
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    UDI-DI
    00841823107527
    PMA / PMN Number
    K163355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER PRODUCT FEEDBACK REPORT ((B)(4)) THAT ALBERTA HEALTH SERVICES- FOOTHILLS MEDICAL CENTRE SENT TO SURGI-ONE ON (B)(6) 2019, THIS EVENT OCCURRED OVER A YEAR AGO ((B)(6) 2018). THIS DATE WAS CONFIRMED WITH THE CUSTOMER. AN AD-TECH INTERNAL COMPLAINT INVESTIGATION WAS PERFORMED FOR THIS ISSUE. SPECIFICALLY, A BATCH RECORD REVIEW WAS CONDUCTED FOR THE IMPACTED DEPTH ELECTRODE AND NO ISSUES WERE NOTED THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT; ALL MANUFACTURED ELECTRODES PASSED THE IN-PROCESS AND FINAL QUALITY CONTROL (QC) CHECKS. ACCORDING TO CUSTOMER PRODUCT FEEDBACK REPORT, THE DEVICE IS AVAILABLE FOR EVALUATION. HOWEVER TO DATE, A PRODUCT RETURN ANALYSIS HAS NOT BEEN PERFORMED FOR THIS COMPLAINT AS AD-TECH IS STILL AWAITING A RESPONSE FROM THE CUSTOMER TO OBTAIN THE PRODUCT FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER. A HISTORICAL COMPLAINTS REVIEW WAS ALSO COMPLETED FOR THE ALLEGED DEFICIENCY "BROKE OFF IN PATIENT". THERE HAS BEEN ONE (1) SIMILAR COMPLAINT FOR A PORTION OF THE DEPTH ELECTRODE BREAKING OFF IN THE PATIENT'S HEAD BETWEEN (B)(6) 2017 AND (B)(6) 2019. THERE HAVE BEEN NO CAPAS OR INVESTIGATIONS IDENTIFIED WITHIN THE TIMEFRAME OF (B)(6) 2016 AND (B)(6) 2019, RELATED TO THE ALLEGED DEFICIENCY "PORTION OF ELECTRODE BROKE OFF IN PATIENT". A RISK ASSESSMENT WAS PERFORMED AND IT WAS FOUND THAT THE CALCULATED OCCURRENCE LEVEL MATCHES THAT OF THE RISK FILES; THUS THE RISK LEVEL REMAINS AT ALAP (AS LOW AS POSSIBLE). THE INVESTIGATION IS STILL ON-GOING AS AD-TECH IS AWAITING FURTHER INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2019 AD-TECH'S CANADIAN DISTRIBUTOR SENT AN EMAIL THAT WAS RECEIVED FROM ONE OF THEIR CUSTOMERS NOTIFYING HIM OF AN ISSUE THEY EXPERIENCED WITH AN AD-TECH DEPTH ELECTRODE. THE REPORT RECEIVED STATED THE FOLLOWING, "PATIENT WAS HAVING FOUR DEPTH ELECTRODES INSERTED FOR EPILEPSY MONITORING. WHEN ATTEMPTING TO ADVANCE ONE ELECTRODE, IT BECAME CAUGHT ON THE DRILLED EDGE OF THE SKULL AND WHEN THE SURGEON ATTEMPTED TO REMOVE IT THE ELECTRODE BROKE OFF AND WAS LODGED IN THE PATIENT'S BRAIN." IN A LATER SECOND SURGERY (TO REMOVE THE THREE REMAINING ELECTRODES), THE PIECE OF THE FOURTH ELECTRODE WAS ALSO REMOVED AT THAT TIME.". ACCORDING TO THE DISTRIBUTOR'S CUSTOMER PRODUCT FEEDBACK REPORT, THERE WAS MINIMUM HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362461 SPENCER PROBE ELECTRODES SPENCER PROBE ELECTRODES GZL AD-TECH MEDICAL INSTRUMENT CORP. N/A 0110671 208140647 00841823107527

    Patients

    Seq Age Sex Outcome Treatment
    1 Other