BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 14251852 · Received April 29, 2022

    Report

    Report Number
    1216677-2022-00128
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 19, 2022
    Report Date
    April 29, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    PMA / PMN Number
    P160047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 REVIEW OF LOT M-210419-03 DID NOT REVEAL ANY ANOMALIES. INCOMING INSPECTION REVIEW NOT REQUIRED FOR THIS INVESTIGATION. SERVICE HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW 1 COMPLAINT ((B)(4)) HAS BEEN REPORTED FOR THE CERVICAL THERMOCOUPLE DETECTING EXCESSIVE HEAT, TRIGGERING ALERT 201. THIS LIKELY ROOT CAUSE IDENTIFIED WAS ATTRIBUTED TO THE PHYSICIAN NOT USING THE SPECIFIED TENACULUM. PRODUCT RECEIPT THE VAPOR PROBE WAS RECEIVED AT AEGEA FOR INVESTIGATION. VISUAL EVALUATION VAPOR PROBE LOT # M-210419-03 WAS OBTAINED FROM THE RETURNED DEVICE BOX. THE PROBE WAS NOT RETURNED IN THE TRAY, NOR DID IT CONTAIN THE TIP COVER. AS A RESULT, THE SHAFT WAS SEVERELY DAMAGED (BENT) IN SHIPPING. SEE PICTURE BELOW. THERE WAS EVIDENCE THE DEVICE HAD BEEN INSERTED INTO THE PATIENT; THERE WAS BLOOD ON THE SHAFT AND TIP. SALINE WAS PRESENT INSIDE THE SYRINGE AND THE SYRINGE CHECK VALVES EXHIBITED MINOR CORROSION, AS EXPECTED, AFTER BEING SUBJECT TO SALINE FOR AN EXTENDED PERIOD OF TIME. FUNCTIONAL EVALUATION - PROBE THE PROBE WAS 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. BALLOON PRESSURES WERE STABLE THROUGHOUT; THERE IS NO INDICATION OF BALLOONS LOSING PRESSURE, MOST RELEVANT BEING THE MIDDLE (SEALING) BALLOON. AIR PUMP ACTIVITY WAS NORMAL (OFF). FISO UTERINE PRESSURE EXPERIENCED AN EXTREMELY BRIEF SPIKE TO 40MM HG DURING THIS PERIOD. BEFORE AND AFTER THE SPIKE, IT WAS LOW (<10). DURING THE FLUSHING PERIOD THE PRESSURE NORMALLY STARTS INCREASING. IN THIS PROCEDURE IT DID NOT. HANDLE ACCELEROMETER VALUES WERE EVALUATED WITH NO SIGNIFICANT FLUCTUATIONS OBSERVED THAT MIGHT BE INDICATIVE OF SUDDEN DEVICE MOVEMENT. HOWEVER, ASSESSMENT OF ACCELEROMETER VALUES FOR THIS PURPOSE IS QUALITATIVE. BASED ON THE TELEMETRY DATA REVIEW, THERE IS NO INDICATION THE CONSOLE OR PROBE DID NOT OPERATE PER SPECIFICATION. THERE IS EVIDENCE VAPOR DID ESCAPE THE UTERUS AND PASSED THE MIDDLE BALLOON, INCREASING THE CERVICAL TC TEMPERATURE AND TRIGGERING ALERT 201. THE PROBE DID PASS THE INTEGRITY TEST PRIOR, SO SOMETHING CHANGED DURING THIS PERIOD OF THE PROCEDURE. THE SPIKE IN PRESSURE INDICATES THE PROBE MAY HAVE MOVED / SHIFTED. USE OF A TENACULUM IS SPECIFIED TO AID IN STABILITY OF THE DEVICE IN THE PATIENT. THE PHYSICIAN WAS ASKED BY COOPER REPRESENTATIVE, ALEX MORRIS, WHETHER A TENACULUM WAS USED IN THIS CASE. THE RESPONSE: "DR. EDELMAN JUST CONFIRMED THAT IN FACT, SHE DID UNHOOK THE TENACULUM FROM THE PROBE DURING THE PRO EDURE." CONCLUSION: THERE IS NO INDICATION THE CONSOLE OR PROBE DID NOT OPERATE PER SPECIFICATION. IT IS BELIEVED THE PROBE SHIFTED DURING THE ABLATION, RESULTING IN VAPOR ESCAPING THE UTERUS. THE PHYSICIAN DID NOT USE A TENACULUM, AS INSTRUCTED IN THE IFU. THIS MAY HAVE BEEN THE CAUSE OF THE ISSUE. THE ONE OTHER COMPLAINT TO DATE THAT REPORTED ALERT 201 (2021-11-0000128) ALSO DETERMINED THAT THE PHYSICIAN DID NOT USE THE SPECIFIED TENACULUM. ROOT CAUSE THE SUSPECTED ROOT CAUSE OF THIS COMPLAINT IS DEVICE MOVEMENT OUT OF POSITION DURING THE PROCEDURE. *CORRECTION AND/OR CORRECTIVE ACTION 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. *WAS THE COMPLAINT CONFIRMED? NO *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI REP. INCIDENT DETAILS- WE HAD A MARA CASE THIS MORNING WITH DR. (B)(6) THE SYSTEM ULTIMATELY PASSED ALL TESTS. IT DID FAIL THE PATENCY TEST ONCE BUT DR. (B)(6) MANEUVERED THE PROBE AND WAS ABLE TO PASS THE TEST THE SECOND TIME. UPON STARTING THE PROCEDURE, THE THERMOCOUPLE DETECTED HEAT, SYSTEM SHUT DOWN AND PATIENT WAS BURNED NEAR CERVIX. DR. (B)(6) TREATED PATIENT AND SHE LEFT THE PRACTICE WITH NO HOSPITALIZATION. THE DOCTOR SAID SHE COULD SEE THE VAPOR ESCAPE THE CAVITY. I HAVE THE PROBE AND WOULD LIKE TO SEND IT IN TO ENGINEERING. MARA PROBE DDK-16-050 E-COMPLAINT( B)(4).

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI REP. INCIDENT DETAILS- WE HAD A MARA CASE THIS MORNING WITH DR. (B)(6)- THE SYSTEM ULTIMATELY PASSED ALL TESTS. IT DID FAIL THE PATENCY TEST ONCE BUT DR. EDELMAN MANEUVERED THE PROBE AND WAS ABLE TO PASS THE TEST THE SECOND TIME. UPON STARTING THE PROCEDURE, THE THERMOCOUPLE DETECTED HEAT, SYSTEM SHUT DOWN AND PATIENT WAS BURNED NEAR CERVIX. DR. (B)(6) TREATED PATIENT AND SHE LEFT THE PRACTICE WITH NO HOSPITALIZATION. THE DOCTOR SAID SHE COULD SEE THE VAPOR ESCAPE THE CAVITY. I HAVE THE PROBE AND WOULD LIKE TO SEND IT IN TO ENGINEERING. 1216677-2022-00128 MARA PROBE DDK-16-050 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308768 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other