BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-DIATHERMY HANDLE, STRAIGHT POINTED TIP.(25 GAUGE / 0.5 MM)

    MDR report key: 19642759 · Received July 1, 2024

    Report

    Report Number
    1222074-2024-00021
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    April 20, 2024
    Report Date
    August 26, 2024
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, A PHOTO WAS PROVIDED FOR REVIEW AND A DIATHERMY HANDPIECE WAS PROVIDED FOR INVESTIGATION. VISUAL INSPECTION OF THE DIATHERMY HANDPIECE SHOWED THAT IT WAS SLIGHTLY BENT, AND THAT THE CONNECTOR IS BECOMING LOOSE, ALTHOUGH STILL WELL SECURED. THE + AND - ENGRAVINGS ON THE CONNECTOR WERE NOT CLEARLY VISIBLE. HANDPIECE FUNCTIONED ACCORDINGLY ALONG WITH THE USE OF THE 1120.A DIATHERMY CABLE. IT COULD BE THAT THE CONNECTOR OF THE DIATHERMY HANDLE IS NOT PLACED ON THE CORRECT POSITION INTO THE CABLE; + ON + AND - ON - , POSSIBLY DUE TO ENGRAVINGS NOT BEING CLEARLY VISIBLE. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS. NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS A RESULT OF THIS INCIDENT. IN-HOUSE CODES PH-HP-PERFORMANCE-PROLONGED, PH-HP-TIP-PERFORMANCE, AND PH-HP-DEFECT WERE CHOSEN TO FIND SIMILAR COMPLAINTS. THE NUMBER OF SIMILAR EVENTS WAS DETERMINED BY TAKING THE REPORTS OF SIMILAR EVENTS BASED ON FAILURE MODES AS REPORTED AND NUMBER OF DIATHERMY DEVICES DISTRIBUTED IN THE GIVEN TIME PERIOD. DUE TO DIATHERMY HANDPIECES AND TIPS BEING RE-USABLE, NUMBER OF SURGERIES PERFORMED IS HIGHER THAN THE NUMBER OF PRODUCTS DISTRIBUTED. NOT ALL OF THE INCIDENTS LED TO PROLONGED SURGERY. THE INCIDENT THAT IS THE SUBJECT OF THIS REPORT IS INCLUDED IN THE TABLE ABOVE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE, OR TRY TO REPLICATE THE PROBLEM ON SIMILAR PRODUCT.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, AND AFTER USING THE ENDOCAUTERY 4 TIMES (4 DIFFERENT SURGERIES) IT STOPPED WORKING. THE CAUTERY WAS NOT USED WITH ANY PRODUCT OTHER THAN THOSE USED IN STANDARD SURGERY AND WAS ALWAYS PROPERLY SANITIZED BEFORE BEING SENT FOR RESTERILIZATION. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED, BUT THE SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING SURGERY, AND AFTER USING THE ENDOCAUTERY 4 TIMES (4 DIFFERENT SURGERIES) IT STOPPED WORKING. THE CAUTERY WAS NOT USED WITH ANY PRODUCT OTHER THAN THOSE USED IN STANDARD SURGERY AND WAS ALWAYS PROPERLY SANITIZED BEFORE BEING SENT FOR RESTERILIZATION. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED, BUT THE SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851763 ENDO-DIATHERMY HANDLE, STRAIGHT POINTED TIP.(25 GAUGE / 0.5 MM) OPEN-SURGERY ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, REUSABLE HQR D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 202304101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown