BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 16159343 · Received January 13, 2023

    Report

    Report Number
    1216677-2022-00345
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 2, 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

    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-211015-01 DID NOT REVEAL ANY ANOMALIES. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW: THIS IS THE FIRST COMPLAINT IN WHICH THE SYRINGE PISTON DID NOT CONNECT TO THE CONSOLE PRODUCT RECEIPT DATE AT AEGEA SITE FOR INVESTIGATION: JANUARY 3, 2023. VISUAL EVALUATION: RETURNED IN ORIGINAL PACKAGING? TRAY MISSING. - NO. EVIDENT PRODUCT HAD BEEN INSERTED INTO PATIENT (BLOOD ON SHAFT, TIP)?- NO. NO SALINE PRESENT INSIDE SYRINGE? (IF YES, SYRINGE REPLACED FOR FUNCTIONAL EVALUATION) - NO 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. BECAUSE THE VAPOR PROBE HAD ONLY PROGRESSED TO THE CONNECTION STATE AND THE SYRINGE WAS DRY, THE PROBE WAS CONNECTED "AS-IS" TO CONSOLE (DV10) IN ATTEMPT TO PERFORM A SIMULATED USE PROCEDURE. AT THE BEGINNING OF SIMULATED USE, THE CONSOLE SYRINGE PUMP "T-BAR" EXTENDS, CONNECTS TO THE SYRINGE PISTON, AND RETRACTS TO DRAW SALINE FROM THE SPIKED BAG. IN THIS TEST, THE T-BAR REACHED, BUT DID NOT CONNECT TO THE PISTON AND THEREFORE DID NOT DRAW IN SALINE. THE REPORTED COMPLAINT WAS CONFIRMED. THE LOCATION OF THE PISTON (4.08" FROM THE BOTTOM OF THE SYRINGE TO THE PISTON) CONFIRMS IT WAS LIKELY PUSHED TO THAT POSITION IN CLINICAL USE. THIS CAN OCCUR IF THE PISTON WAS MISALIGNED WITH RESPECT TO THE T-BAR. PISTON LOCATION REPORTED ISSUE CONFIRMED. THE ROOT CAUSE COULD BE INADVERTENT MOVEMENT OF THE PISTON CAUSED BY THE USER DURING DEVICE PREPARATION. OR, IT COULD HAVE BEEN CAUSED BY MANUFACTURING NOT CORRECTLY INSTALLING THE PISTON. FOR TRENDING PURPOSES, THE ROOT CAUSE WILL BE ATTRIBUTED TO MANUFACTURING AS THE MOST PROBABLE CAUSE. NO ACTION IS REQUIRED GIVEN THIS IS THE FIRST COMPLAINT OF THIS TYPE. *CORRECTION AND/OR CORRECTIVE ACTION /*PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT DR'S "ATTEMPTED TO DO A MARA BUT THEY STATED THAT THE SYRINGE WOULD NOT FILL UP WITH SALINE ONCE ILLUMINATED GREEN ON TOP OF THE MARA CONSOLE." " THIS WAS THE ONLY PROBE THAT THEY HAD ON HAND SO THEY WERE UNABLE TO COMPLETE THE PROCEDURE." "PATIENT WAS NOT ABLE TO BE TREATED AFTER HAVING GONE THROUGH SEDATION." 1216677-2022-00345 MARA PROBE DDK-16-050 (B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT: DR'S "ATTEMPTED TO DO A MARA BUT THEY STATED THAT THE SYRINGE WOULD NOT FILL UP WITH SALINE ONCE ILLUMINATED GREEN ON TOP OF THE MARA CONSOLE." "THIS WAS THE ONLY PROBE THAT THEY HAD ON HAND SO THEY WERE UNABLE TO COMPLETE THE PROCEDURE." "PATIENT WAS NOT ABLE TO BE TREATED AFTER HAVING GONE THROUGH SEDATION." MARA PROBE DDK-16-050 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018293 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other