BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 16159468 · Received January 13, 2023

    Report

    Report Number
    1216677-2022-00344
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 16, 2022
    Report Date
    March 17, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    PMA / PMN Number
    P160047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-REVIEW DHR , X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS, (B)(4). WAS THE COMPLAINT CONFIRMED? YES. MANUFACTURING RECORD REVIEW APPLICABLE: REVIEW OF RECORDS FOR LOT M-2205511-01 DID NOT REVEAL ANY ANOMALIES. INCOMING INSPECTION REVIEW NOT APPLICABLE. SERVICE HISTORY RECORD NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW ALERT 176 IS THE MOST REPORTED SYMPTOM CODE. ALERT 117 IS THE SECOND MOST REPORTED SYMPTOM CODE. ALERT 120 HAS BEEN REPORTED ONCE, WITH NO DEFECT CONFIRMED. ALERT 123 HAS NOT BEEN REPORTED. PRODUCT RECEIPT DATE AT AEGEA SITE FOR INVESTIGATION: JANUARY 23, 2023 VISUAL EVALUATION. RETURNED IN ORIGINAL PACKAGING? NO MISSING TRAY: #1, 3, 4. EVIDENT PRODUCT HAD BEEN INSERTED INTO PATIENT (BLOOD ON SHAFT, TIP)? NO NO SALINE PRESENT INSIDE SYRINGE? (IF YES, SYRINGE REPLACED FOR FUNCTIONAL EVALUATION) YES 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. *EEPROM RECORDS THE LAST 2 OCCURRING ALERTS. IF TWO ALERTS ARE LISTED, IT IS POSSIBLE ADDITIONAL, PRIOR ALERTS MAY HAVE OCCURRED. PROBE 1: UNABLE TO REPLICATE. PASSED SIMULATED USE, PERFORMED PER SPECIFICATION. NO ALERTS. BASED ON THE EEPROM, THE PROBE EXPERIENCED ALERT 123. THIS WAS NOT ABLE TO BE CONFIRMED. CAUSE IS UNKNOWN, POSSIBLY DUE TO A CONNECTION OR TIP COVER ISSUE. (ALERT 130 WAS DUE TO A SYRINGE DISCONNECTION, LIKELY INTENTIONAL IN THE SEQUENCE OF DISCONNECTION.) PROBE 2: REPORTED ISSUE CONFIRMED. DID NOT PASS SIMULATED USE. ALERT 176 OCCURRED TWICE. THE HEATING COIL DID NOT RISE 5°C DURING THE TEST. PROBE 3: REPORTED ISSUE CONFIRMED. PASSED SIMULATED USE, BUT ALERT 117 OCCURRED TWICE FIRST. ON THE THIRD ATTEMPT THE TEST PASSED. THIS SCENARIO TYPICALLY OCCURS DUE TO A POOR SEAL BETWEEN THE MIDDLE BALLOON AND TIP COVER. ALERT 189 COULD NOT BE CONFIRMED; IT WAS LIKELY DUE TO DISCONNECTION OF THE PROBE. PROBE 4: UNABLE TO REPLICATE. PASSED SIMULATED USE, PERFORMED PER SPECIFICATION. BASED ON THE EEPROM, THE PROBE EXPERIENCED ALERT 120. THIS WAS NOT ABLE TO BE CONFIRMED, NOR OCCURRED DURING TESTING. ALERT 199 IS TRIGGERED BY THE USER PRESSING THE E-STOP BUTTON. CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT. "PROBE WOULD NOT PASS THE PROBE SELF TEST. WE NEVER MADE IT TO THE SECOND CHECK MARK." "PATIENT WAS UNDER ANESTHESIA. SHE WAS UNDER ANESTHESIA FOR AN EXTENDED PERIOD OF TIME DUE TO ALL THE ALERTS." MARA PROBE DDK-16-050 E-COMPLAINT: (B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT "PROBE WOULD NOT PASS THE PROBE SELF TEST. WE NEVER MADE IT TO THE SECOND CHECK MARK." "PATIENT WAS UNDER ANESTHESIA. SHE WAS UNDER ANESTHESIA FOR AN EXTENDED PERIOD OF TIME DUE TO ALL THE ALERTS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528335 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other