BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 13825208 · Received March 19, 2022

    Report

    Report Number
    1216677-2022-00084
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    February 12, 2022
    Report Date
    March 18, 2022
    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 MANUFACTURING RECORD REVIEW THE LOT HISTORY WAS REVIEWED AN NO MANUFACTURING OR INSPECTION ANOMALIES WERE OBSERVED. SPECIFICALLY RELEVANT TO PROBE A, THE FISO ACCURACY MEASURED WITHIN -.1MM HG ACCURACY, WELL WITHIN THE SPECIFICATION OF ±3MM HG. INCOMING INSPECTION REVIEW NOT REQUIRED FOR THIS INVESTIGATION. SERVICE HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW ALERT 117 HAS BEEN REPORTED IN 4 COMPLAINTS INCLUDING THIS COMPLAINT (APRIL 1, 2021-MARCH 31, 2022). THE DEVICE PERFORMED PER SPECIFICATION IN 2 INVESTIGATIONS. THE MIDDLE BALLOON WAS UNDERSIZE IN 1 INVESTIGATION. THERE IS 1 INVESTIGATION PENDING DEVICE RETURN. PRODUCT RECEIPT THE VAPOR PROBES WERE RECEIVED AT AEGEA FOR INVESTIGATION ON 4/6/2022. VISUAL EVALUATION VAPOR PROBE LOT # M-210219-02 WAS OBTAINED FROM THE RETURNED DEVICE BOX FOR THE TWO PROBES. THERE COMPLAINT (B)(4) INVESTIGATION (B)(4) WAS NO EVIDENCE THE DEVICES HAD BEEN INSERTED INTO THE PATIENT, CONSISTENT WITH THE REPORT. SALINE WAS PRESENT INSIDE THE SYRINGE OF PROBE A AND THE SYRINGE CHECK VALVES EXHIBITED MINOR CORROSION, AS EXPECTED, AFTER BEING SUBJECT TO SALINE FOR AN EXTENDED PERIOD OF TIME. FUNCTIONAL EVALUATION THE PROBES WERE CONNECTED TO AN INSPECTION STATION EQUIVALENT TO THE HANDLE SUB-ASSEMBLY FINAL INSPECTION WORKSTATION (A 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, PRIOR ALERTS MAY HAVE OCCURRED. PROBE A: IN ORDER TO EVALUATE THE VAPOR PROBE USING A CONSOLE, THE EEPROM WAS RESET AND THE USED SYRINGE WAS REPLACED WITH ONE THAT DID NOT HAVE CORRODED CHECK VALVES. THE PROBE WAS CONNECTED TO CONSOLE (DV10) TO ATTEMPT TO PERFORM A SIMULATED USE PROCEDURE. SIMULATED USE PASSED WITHOUT ALERTS. THE DEVICE PERFORMED PER SPECIFICATION. THE ROOT CAUSE OF ALERT 117 THAT OCCURRED CLINICALLY WAS NOT ABLE TO BE REPLICATED. ALERT 117 CAN BE TRIGGERED DUE TO ONE OF THREE POSSIBLE ISSUES (SEE APPENDIX A). NONE OF THESE PRESENTED IN SIMULATED USE. THE MOST LIKELY REASON IT OCCURRED WAS AN INADEQUATE SEAL BETWEEN THE MIDDLE BALLOON AND TIP COVER OR BETWEEN THE PROBE AND CARTRIDGE REFERENCE AIR LINE. THE OTHER CAUSES (HIGH PRESSURE OR FISO INACCURACY) WOULD HAVE PRESENTED IN SIMULATED USE DURING THE INVESTIGATION. THE COMMENT THAT THE PROBE WAS STUCK ON THE CARTRIDGE MAKES SENSE CONSIDERING THE LAST ALERT RECORDED WAS 130, SYRINGE UNEXPECTEDLY DETACHED FROM CONSOLE (SEE APPENDIX B). TO PROPERLY QUIT THE ATTEMPTED PROCEDURE, THE USER SHOULD HAVE PRESSED THE E-STOP BUTTON FIRST. IF THEY HAD DONE SO, ALERT 199 WOULD HAVE BEEN RECORDED ON THE EEPROM, AND NOT ALERT 130. THIS IS FURTHER CONFIRMED BY THE USER COMMENT THAT ONE OF THE PINCH VALVE PINS WAS STICKING OUT OF THE CARTRIDGE. THE CONSOLE WOULD HAVE RELEASED THE CARTRIDGE HAD THE E-STOP BUTTON BEEN DEPRESSED. USER ERROR WAS THE CAUSE OF THE DIFFICULTY IN REMOVING THE PROBE FROM THE CARTRIDGE. PROBE B: THE PROBE WAS CONNECTED TO CONSOLE (DV10) TO ATTEMPT TO PERFORM A SIMULATED USE PROCEDURE. (BECAUSE THE PROBE STATE WAS "UNUSED" THE EEPROM DID NOT NEED TO BE RESET, NOR DID THE DRY SYRINGE NEED BE REPLACED.) SIMULATED USE WAS ATTEMPTED AND ALERT 130 OCCURRED (SYRINGE DISCONNECTION). A SECOND ATTEMPT PASSED WITH NO ALERTS. ALERT 186 WAS NOT REPLICATED. IT IS POSSIBLE DURING THE CASE THAT THE USER HAD AFFECTED THE CARTRIDGE WHEN REMOVING THE FIRST PROBE IN A MANNER THAT DID NOT ALLOW THE SECOND PROBE TO CONNECT PROPERLY. CONSOLE DATA WAS NOT AVAILABLE FOR THE INVESTIGATION. IN SUMMARY, THE REPORTED ISSUE WAS NOT ABLE TO BE REPLICATED FOR EITHER PROBE. ALERT 117 MAY HAVE MITIGATED ITSELF DUE TO THE MIDDLE BALLOON SEATING BETTER DURING THIS RETEST. THERE WAS USER ERROR IN REMOVAL OF THE FIRST PROBE WHICH MAY HAVE LED TO ISSUES CONNECTING THE SECOND PROBE. ROOT CAUSE THE ROOT CAUSE OF ALERT 117 HAS NOT BEEN CONFIRMED; IT MAY HAVE BEEN DUE TO INADEQUATE MIDDLE BALLOON SEALING AGAINST THE TIP COVER OR BETWEEN THE PROBE AND CARTRIDGE DURING THE CASE. THE ROOT CAUSE OF REPORTED ALERT 186 HAS NOT BEEN CONFIRMED; IT MAY HAVE BEEN DUE USER ERROR IN REMOVAL OF THE FIRST PROBE WHICH MAY HAVE LED TO ISSUES CONNECTING THE SECOND PROBE. *CORRECTION AND/OR CORRECTIVE ACTION NONE REQUIRED AT THIS TIME. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. 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. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT: WE HAD A REOCCURRING ALERT MESSAGE (117) PROBE SENSOR CALIBRATION ISSUE. WE MADE SURE PROBE WAS SECURE AND THAT THE CLEAR PROBE COVER WAS ON PROPERLY. WE TRIED TO CONTINUE THREE TIMES. MESSAGE KEPT COMING UP AFTER 1 GREEN CHECK MARKS DURING PROBE SELF TEST. TRIED TO REPLACE PROBE AND IT WAS STUCK ON CARTRIDGE. FINALLY GOT IT OFF AND REALIZED ONE OF THE SILVER PINS WAS STICKING OUT OF THE BLACK CARTRIDGE. WE OPENED A SECOND PROBE AND HAD TROUBLE GETTING IT ON DUE TO THE PIN STICKING OUT. ONE WE HAD IT ON WE STARTED THE ENTIRE PROCESS OVER AGAIN. THIS TIME WE HAD THE MESSAGE ERROR (186) VAPOR PROBE MEMORY ERROR. UNABLE TO COMPLETE ABLATION. I BELIEVE THE BLACK CARTRIDGE WAS DAMAGED AND THIS ACCOUNT WILL NEED A REPLACEMENT UNIT AND TWO REPLACEMENT PROBES. I HAVE THE TWO PROBES AND THE MARA CONSOLE IS AT THE ACCOUNT. AFTER THIS INCIDENT I WAS TOLD THAT THE RED INTERRUPT BUTTON WOULD HAVE NEEDED TO BE HIT AFTER THE PROBE SELF TEST HAS STARTED. THIS IS THE ONLY WAY TO REMOVE PROBE FROM CARTRIDGE. I'VE HAD PROBE ISSUES BEFORE AND THIS BUTTON WAS NOT TAPPED. I BELIEVE IT WAS BC THE ISSUE HAPPENED BEFORE THE PROBE SELF TEST IN THE PAST. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? BEFORE. PATIENT INVOLVEMENT? YES. ANY PATIENT INJURY? NO. MEDICAL OR PROCEDURAL INTERVENTION? NO. PATIENT STATUS: THE PROBE WAS NEVER INSERTED INTO THE PATIENT. PATIENT WAS UNDER GENERAL ANESTHESIA. MARA PROBE DDK-16-050 (B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT WE HAD A REOCCURRING ALERT MESSAGE (117) PROBE SENSOR CALIBRATION ISSUE. WE MADE SURE PROBE WAS SECURE AND THAT THE CLEAR PROBE COVER WAS ON PROPERLY. WE TRIED TO CONTINUE THREE TIMES. MESSAGE KEPT COMING UP AFTER 1 GREEN CHECK MARKS DURING PROBE SELF TEST. TRIED TO REPLACE PROBE AND IT WAS STUCK ON CARTRIDGE. FINALLY GOT IT OFF AND REALIZED ONE OF THE SILVER PINS WAS STICKING OUT OF THE BLACK CARTRIDGE. WE OPENED A SECOND PROBE AND HAD TROUBLE GETTING IT ON DUE TO THE PIN STICKING OUT. ONE WE HAD IT ON WE STARTED THE ENTIRE PROCESS OVER AGAIN. THIS TIME WE HAD THE MESSAGE ERROR (186) VAPOR PROBE MEMORY ERROR. UNABLE TO COMPLETE ABLATION. I BELIEVE THE BLACK CARTRIDGE WAS DAMAGED AND THIS ACCOUNT WILL NEED A REPLACEMENT UNIT AND TWO REPLACEMENT PROBES. I HAVE THE TWO PROBES AND THE MARA CONSOLE IS AT THE ACCOUNT. * AFTER THIS INCIDENT I WAS TOLD THAT THE RED INTERRUPT BUTTON WOULD HAVE NEEDED TO BE HIT AFTER THE PROBE SELF TEST HAS STARTED. THIS IS THE ONLY WAY TO REMOVE PROBE FROM CARTRIDGE. I'VE HAD PROBE ISSUES BEFORE AND THIS BUTTON WAS NOT TAPPED. I BELIEVE IT WAS BC THE ISSUE HAPPENED BEFORE THE PROBE SELF TEST IN THE PAST. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? BEFORE PATIENT INVOLVEMENT? YES ANY PATIENT INJURY ? NO MEDICAL OR PROCEDURAL INTERVENTION? NO PATIENT STATUS THE PROBE WAS NEVER INSERTED INTO THE PATIENT. PATIENT WAS UNDER GENERAL ANESTHIA. 1216677-2022-00084 MARA PROBE DDK-16-050 (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290885 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other