BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 16354606 · Received February 10, 2023

    Report

    Report Number
    1216677-2023-00024
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 7, 2023
    Report Date
    May 1, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    PMA / PMN Number
    P160047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS E-COMPLAINT (B)(4). MANUFACTURING RECORD REVIEW M-220711-02 WAS REVIEWED AND NO ANOMALIES WERE OBSERVED. (MFG ID #43 WO (B)(4)). INCOMING INSPECTION REVIEW NOT APPLICABLE. SERVICE HISTORY RECORD NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW ALERT 189 HAS A LOW OCCURRENCE RATE, WITH LESS THAN 4 INSTANCES IN THE PAST YEAR. MARA COMPLAINT TRENDING, FEB 2023. PRODUCT RECEIPT DATE AT AEGEA SITE FOR INVESTIGATION: FEBRUARY 20, 2023. FUNCTIONAL EVALUATION METHOD: PROBE CONNECTED TO INSPECTION STATION EQUIVALENT TO THE HANDLE SUB-ASSEMBLY FINAL INSPECTION WORKSTATION (CARTRIDGE CONDUIT ADAPTER (TL0264) CONNECTED TO THE FISO IQC HARDWARE (TL0185) AND FISO IQC SOFTWARE (TL0186)) TO READ AND RECORD THE PROBE'S EEPROM DATA. IN ORDER TO CONDUCT SIMULATED USE WITH A CONSOLE, THE EEPROM IS RESET AND THE USED SYRINGE REPLACED WITH ONE WITHOUT CORRODED CHECK VALVES. THE VAPOR PROBE IS CONNECTED TO CONSOLE (DV10) AND SIMULATED USE IS ATTEMPTED. REPORTED ISSUE NOT CONFIRMED: ALERT 189THE PROBE WAS "UNUSED" PER THE EEPROM DATA. AND, NO SALINE WAS PRESENT IN THE SYRINGE. THEREFORE, THE REASON FOR RETURN IS MOST LIKELY RELATED TO A CONNECTION ISSUE. FROM THE REPORTED ISSUE, WHICH APPLIES TO 4 DEVICES RETURNED OVER 2 COMPLAINTS (ALSO (B)(4)), ONLY ALERT 189 COULD BE APPLICABLE TO THIS PROBE. ALERT 189 OCCURS "IF ALL THREE PROBE TCS BECOME DETACHED FOR 1 SECOND AFTER PROBE ASSEMBLY". SIMULATED USE WAS ATTEMPTED. ALERT 189 DID NOT OCCUR, AND THE SYRINGE FILLED WITH SALINE. AT THIS POINT, THERE WAS NO REASON TO CONTINUE THROUGH THE FULL ABLATION. THE REPORTED ISSUE WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT REPORTED ON INCOMING (B)(4): "WHILE ATTEMPTING TO PERFORM A MARA GLOBAL ENDOMETRIAL ABLATION PROCEDURE 3 OUT OF THE 4 PROBES FAILED. THEY PRODUCED ERROR CODES 117, 176 ,189. THE PHYSICIAN HAD TO USE A MINERVA TO COMPLETE THE PROCEDURE."

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT REPORTED ON INCOMING (B)(4): "WHILE ATTEMPTING TO PERFORM A MARA GLOBAL ENDOMETRIAL ABLATION PROCEDURE 3 OUT OF THE 4 PROBES FAILED. THEY PRODUCED ERROR CODES 117, 176 ,189. THE PHYSICIAN HAD TO USE A MINERVA TO COMPLETE THE PROCEDURE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44456 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other