BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 14138857 · Received April 18, 2022

    Report

    Report Number
    1216677-2022-00110
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 18, 2022
    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

    THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR: INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS: MANUFACTURING RECORD REVIEW: LHR REVIEW FOR VAPOR PROBE LOT # M-210826-02: THE FISO SERIAL NUMBER CORRELATES TO MFG #115. REVIEW OF THE MANUFACTURING AND INSPECTION DATA DID NOT REVEAL ANY ANOMALIES (E.G. NCMRS, DEVIATIONS, RESULTS). MOST APPLICABLE TO THIS INVESTIGATION, THE INTEGRITY SENSOR VALUE WAS MEASURED TO BE 126.2. THE SPECIFICATION IS 100-135. ALL OTHER DEVICES WERE IN THE 122-125 RANGE. INTEGRITY FLOW AND DRIVE PRESSURE WERE ALSO IN SPECIFICATION AND CONSISTENT WITH THE REST OF THE LOT. THERE IS NO INDICATION THAT MANUFACTURING DATA FOR THIS LOT CONTRIBUTED TO THE REPORTED ISSUE. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW WAS NOT APPLICABLE TO THE INVESTIGATION OF THE REPORTED COMPLAINT ISSUE. INCOMING INSPECTION RECORD REVIEW IS APPLICABLE TO THE MANUFACTURING DEFECT IDENTIFIED IN THE FUNCTIONAL EVALUATION SECTION BELOW. THIS WILL BE ADDRESSED SEPARATELY; SEE CORRECTIVE ACTION SECTION. SERVICE HISTORY RECORD: SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: FIVE OCCURRENCES OF PATENCY CHECK FAILURES HAVE BEEN REPORTED TO DATE. (B)(4). UNABLE TO REPLICATE ISSUE. PROBE DID EXHIBIT ISSUES, BUT UNRELATED TO PATENCY. (B)(4). UNABLE TO REPLICATE ISSUE. RETURN PROBE PERFORMED PER SPECIFICATION. (B)(4). PENDING PRODUCT RETURN. (B)(4). PENDING PRODUCT RETURN. (B)(4). PENDING PRODUCT RETURN. PRODUCT RECEIPT: THE VAPOR PROBE WAS RETURNED ON 3/29/2022. VISUAL EVALUATION: VAPOR PROBE LOT # M-210826-02 WAS OBTAINED FROM THE RETURNED DEVICE BOX. THE PROBE TIP DID HAVE BLOOD ON THE TIP, INDICATING IT HAD BEEN INSERTED INTO A PATIENT, AND IN THE ORIGINAL PACKAGING TRAY, BUT THE TIP COVER WAS NOT PRESENT. 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: THE PROBE WAS CONNECTED TO AN INSPECTION STATION EQUIVALENT TO THE HANDLE SUB-ASSEMBLY FINAL INSPECTION WORK STATION (A CARTRIDGE CONDUIT ADAPTE (TL0264) CONNECTED TO THE FISO IQC HARDWARE (TL0185) AND FISO IQC SOFTWARE (TL0186)) TO READ AND RECORD THE PROBE'S EEPROM DATA. DATA SHOWED THAT THE VAPOR PROBE WAS IDENTIFIED BY FISO PRESSURE SENSOR SERIAL #: (B)(6). THE CONSOLE USED FOR THE PROCEDURE IS AEGQ-2054. THE DATA INDICATED THE LAST STATE WAS VAPOR PROBE TEST. THERE WERE NO ALERTS RECORDED. THIS INCLUDES NO INDICATION OF THE E-STOP BEING PRESSED OR DISCONNECTION OF THE VAPOR PROBE (199 OR 197, RESPECTIVELY). THE EEPROM WAS RESET AND THE USED SYRINGE WAS REPLACED WITH ONE THAT DID NOT HAVE CORRODED CHECK VALVES. THE PROBE WAS CONNECTED TO CONSOLDE (DV10) TO ATTEMPT TO PEROFMR A SIMULATED USE PROCEDURE. SIMULATED USE WAS CONDUCTED WITH NO ISSUES / ALERTS. PATENCY PASSED FIRST TIME. DURING VAPOR DELIVARY, IT WAS NOTICED THAT VAPOR WAS EXITING THE OUTFLOW TUBE TOWARD THE TOP/HANLE END. THIS CONFIRMED AN OBSERVATION DURING THERMAL CALIBRATION, PRIOT TO "PATIENT" INSERTION IN THE SILICONE UTERUS, THAT WATER / VAPOR WAS PRESENT JUST BELOW THE HANDLE. AFTER SIMULATED USE, THE OUTFLOW TUBE WAS INSPECTED AND IT WAS DISCOVERED THA (8) SIDE EXIT HOLES WERE ON THE WRONG END OF THE OUTFLOW TUBE. AEGEA RISK ANALYSIS, DESIGN RMEA RA0031 REV 09 ITEM 31-19, MOST CLOSELY CORRELATES TO THE OUTFLOW ISSUE THAT WAS IDENTIFIED. IT CLASSIFIES THE EFFECT OF AN OUTFLOW RELATED VAPOR LEAK AS "POTENTIAL THERMAL INJURY TO OPERATING PHYSICIAN OR PATIENT", SEVERITY 3 (MODERATE; THE HAZARD/FAILURE MAY REQUIRE MEDICAL ATTENTION TO FULLY MITIGATE THE HAZARD). THE OUTFLOW TUBE ASSEMBLY IS MANUFACTURED BY A SUPPLIER, NEXTERN INC. THEIR RISK ANALYSIS, PROCESS FMEA D102036 REV F, DOES NOT CONTEMPLATE THIS ASSEMBLY PROCESS DEFECT. THE CLOSEST FAILURE MODE AND EFFECT ARE ITEM 2: "...TUBE LEAKS FROM UNINTENDED LOCATIONS" LEADING TO "POTENTIAL THERMAL INJURY TO OPERATING PHYSICIAN OR PATIENT", SEVERITY 3. THE RISK ANALYSIS' CLEARLY CLASSIFY OUTFLOW RELATED VAPOR LEAKS AS A POTENTIAL SAFETY ISSUE. MANUFACTURING CONTROLS FOR OUTFLOW TUBE ASSEMBLY: NEXTERN INSPECTION: MANUFACTURING PROCEDURE - OUTFLOW TUBE SUBASSEMBLY (D101782 REV B) SECTION 4.4.1 VISUAL INSPECTION: VERIFY QTY 8 (FOUR X 2) HOLES ARE PUNCHED THROUGH SILICONE TUBING COOPERSURGICAL IQC: OUTFLOW TUBE SUB-ASSEMBLY (PT0064-06 REV A) SECTION 6.4.1 VISUALLY INSPECT AQL 1.0: VERIFY ALL HOLES ARE PRESENT THE CONSOLE WAS NOT AVAILABLE FOR INVESTIGATION. THERE IS NO REASON TO SUSPECT A CONSOLE ISSUE BASED ON THE INFORMATION RECEIVED OR INVESTIGATION OF THE VAPOR PROBE. ROOT CAUSE: THE REPORTED COMPLAINT OF NOT BEING ABLE TO PASS THE PATENCY TEST WAS NOT ABLE TO BE REPLICATED FOR THIS DEVICE. DURING TESTING, THE DEVICE PERFORMED PER SPECIFICATION. IT IS POSSIBLE THERE WERE ANATOMICAL OR DEVICE PALCEMENT FACTORS THAT LED TO THE TEST FAILURE. THE ROOT CAUSE OF THE OUTFLOW TUBE BEING MANUFACTURED INCCORECTLY IS DUE TO SUPPLIER ERROR. CORRECTIVE ACTION: REPORTED PATENCY FAILURE: NO CORRECTIVE ACTION REQUIRED. OUTFLOW TUBE INCORRECTLY MANUFACTURED: SUPPLIED CORRECTIVE ACTION SCA-007 ISSUED TO SUPPLIED, NEXTERN INC., ON 4/8/2022.

    Description of Event or Problem · 0

    REPORT STATED- 2 FAILED PROBES- BOTH PROBES WOULD NOT PASS THE PATENCY TEST IN THEIR RESPECTIVE CASES. THESE PROBES WERE FAILURES FOR 2 DIFFERENT PATIENTS. IN BOTH CASES, AFTER ALL TROUBLESHOOTING WAS COMPLETE, THE PROBE WAS SWAPPED FOR A NEW ONE AND THE SYSTEM IMMEDIATELY PASSED THE CHECKS AND WAS ABLE TO COMPLETE THE CASE. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? NO ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO MEDICAL OR PROCEDURAL INTERVENTION? NO PATIENT/GAMETE/EMBRYO STATUS N/A 1216677-2022-00110 MARA PROBE DDK-16-050 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    REPORT STATED- 2 FAILED PROBES- BOTH PROBES WOULD NOT PASS THE PATENCY TEST IN THEIR RESPECTIVE CASES. THESE PROBES WERE FAILURES FOR 2 DIFFERENT PATIENTS. IN BOTH CASES, AFTER ALL TROUBLESHOOTING WAS COMPLETE, THE PROBE WAS SWAPPED FOR A NEW ONE AND THE SYSTEM IMMEDIATELY PASSED THE CHECKS AND WAS ABLE TO COMPLETE THE CASE. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? NO. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO. MEDICAL OR PROCEDURAL INTERVENTION? NO. PATIENT/GAMETE/EMBRYO STATUS N/A. 1216677-2022-00110-1 MARA PROBE DDK-16-050 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52437 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 M-210826-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other