BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARA PROBE

    MDR report key: 14375396 · Received May 12, 2022

    Report

    Report Number
    1216677-2022-00146
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    August 3, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    PMA / PMN Number
    P160047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 OF VAPOR PROBE LOT M-211223-01 WAS PERFORMED. RELEVANT TO THE BALLOON INFLATION ISSUES DISCUSSED IN DEVICE INVESTIGATIONS (FUNCTIONAL EVALUATION - PROBE BELOW), LOT HISTORY RECORDS (LHRS) WERE REVIEWED TO TRACE BACK TO THE HOLE DRILLING PROCESS IN THE MLE SUB-ASSEMBLY. THIS PROCESS IS WHEN IN THE PEBAX IS DRILLED TO CREATE THE BALLOON INFLATION PATHWAY BETWEEN THE SHAFT LUMEN AND THE BALLOON THAT IS ASSEMBLED ON THE SHAFT. TWO LOTS OF THE MLE SUB-ASSEMBLIES WERE USED IN THIS VAPOR PROBE BUILD, ONE OF WHICH HAD A HIGHER THAN TYPICAL REJECT RATE. LOT M-211129-05, WHICH WAS USED FOR 47 OF THE DEVICES IN THIS VAPOR PROBE LOT, HAD 42 REJECTS FOR HOLE DRILLING, WHICH TAKE THE FORM OF INCOMPLETE OR PARTIALLY DRILLED HOLES, OR HOLES DRILLED TOO DEEP THAT PUNCH THROUGH THE OPPOSITE WALL OF THE LUMEN. THIS HIGH REJECT RATE WAS ATTRIBUTED TO A NEW ASSEMBLER IN-TRAINING. IT IS LIKELY THAT THE INCOMPLETE HOLE DISCOVERED DURING THE INVESTIGATION WAS SIMILARLY ASSOCIATED WITH THE NEW ASSEMBLER BECAUSE MLE SUB-ASSEMBLY BUILDS BEFORE AND AFTER THIS LOT DID NOT EXHIBIT THIS ISSUE AT THIS REJECT RATE. INCOMING INSPECTION REVIEW NOT REQUIRED FOR THIS INVESTIGATION. SERVICE HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW OF COMPLAINT INVESTIGATIONS FROM MAY 1, 2021 THROUGH MAY 18, 2022: PATENCY/INTEGRITY: 7 REPORTED. INVESTIGATION RESULTS: 5: NOT CONFIRMED. VAPOR PROBE PERFORMED PER SPECIFICATION 1: CONFIRMED: FLUID SENSOR VALUE INCORRECT 1: USER ERROR BALLOON DEFLATION: THIS IS THE FIRST REPORTED COMPLAINT FOR BALLOONS NOT DEFLATING PRODUCT RECEIPT TWO VAPOR PROBES WERE RECEIVED AT AEGEA FOR INVESTIGATION ON 5/13/2022. VISUAL EVALUATION VAPOR PROBES, LOT # M-211223-01, WERE OBTAINED FROM THE RETURNED DEVICE BOX. THE PROBES WERE NOT RETURNED IN THEIR TRAYS, NOR DID THEY CONTAIN TIP COVERS. AS A RESULT, THE SHAFTS WERE DAMAGED (BENT) IN SHIPPING. SEE PICTURES BELOW. THERE WAS EVIDENCE THE DEVICES HAD BEEN INSERTED INTO THE PATIENT, THE SHAFT AND TIP WERE BLOODY. 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 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. PROBE A: ALERT 101: INDICATES A HIGH CERVICAL THERMOCOUPLE TEMPERATURE BEFORE VAPOR TREATMENT HAS BEEN INITIATED. THIS IS DUE TO THE VAPOR PROBE TEST SEQUENCE, TYPICALLY RESIDUAL HEAT AFTER THE THERMAL CALIBRATION STEP HAS COMPLETED. IN THIS CASE IT WAS CLEARED AND THE CASE PROCEEDED. THIS IS BELIEVED TO BE UNRELATED TO THE REPORTED COMPLAINT. ALERT 201: INDICATES A HIGH CERVICAL THERMOCOUPLE TEMPERATURE DURING VAPOR DELIVERY. THIS, ALONG WITH THE LAST USAGE STATE OF "TREATMENT STARTED" CONFIRMS THAT VAPOR DELIVERY WAS INITIATED FOR THIS DEVICE, WHICH MEANS THE DEVICE DID PASS THE INTEGRITY AND PATENCY TESTS (POSSIBLY AFTER MORE THAN 1 ATTEMPT). THIS ALERT IS TYPICALLY CAUSED BY REPOSITIONING THE PROBE RESULTING IN AN INADEQUATE SEAL BETWEEN THE MIDDLE BALLOON AND THE CERVIX. A GOOD SEAL WAS CONFIRMED PRIOR BY PASSING THE INTEGRITY TEST. BALLOON FUNCTION TO SPECIFICATION WAS CONFIRMED (BELOW) IN THE RETURN DEVICE EVALUATION, SO A DEVICE MALFUNCTION HAS NOT BEEN OBSERVED. FUNCTIONAL EVALUATION OF THE PROBE BY RUNNING SIMULATED USE WAS NOT POSSIBLE BECAUSE THE FISO PRESSURE SENSOR WAS NO LONGER WORKING DUE TO A BROKEN FIBER OPTIC CABLE CAUSED BY THE SHAFT DAMAGE DURING RETURN SHIPMENT. THERE IS NO INDICATION FROM THE EEPROM DATA THAT THIS BREAK OCCURRED CLINICALLY. SO, SPECIFIC TESTS WERE ATTEMPTED WITH THE CONSOLE IN ENGINEERING MODE TO EVALUATE THE REPORTED COMPLAINT ISSUES: THE REPORTED ISSUE REGARDING THE INTEGRITY AND PATENCY TESTS COULD NOT BE CONFIRMED DUE TO THE DEVICE CONDITION. HOWEVER, IT IS KNOWN THROUGH THE EEPROM DATA THAT THE DEVICE DID PASS THESE TESTS. IT IS UNKNOWN IF THIS TOOK MORE THAN 1 ATTEMPT REPORTED BALLOON LACK OF DEFLATION: EACH BALLOON WAS INFLATED USING THE CONSOLE'S ENGINEERING MODE. THE BALLOONS WERE BROUGHT UP TO OPERATING PRESSURES AND WERE STABLE PER DEVICE SPECIFICATIONS. EACH BALLOON WAS THEN DEFLATED WITH PARTICULAR ATTENTION PAID TO THE EXTERNAL BALLOON (THE "VAGINAL VAULT" BALLOON, AS REPORTED) THAT WAS STATED TO HAVE STAYED INFLATED. IT DID REMAIN VISIBLY INFLATED. TOUCHING THE BALLOON REVEALED THAT IT WAS NO LONGER FULLY PRESSURIZED, HOWEVER. UPON GENTLE SQUEEZING THE BALLOON DEFLATED. THIS TEST SHOWED THAT THE EXTERNAL BALLOON WAS NOT ACTIVELY BEING INFLATED OR HELD AT FULL PRESSURE WHEN THE SYSTEM WAS SET TO DEFLATE THE BALLOON. HOWEVER, PRESSURE WAS NOT RELIEVED AS QUICKLY AS IS TYPICAL. THIS DEFLATION ASSESSMENT WAS REPEATED WITH AND WITHOUT THE CONSOLE CARTRIDGE ATTACHED TO THE PROBE WITH MINIMALLY DIFFERENT RESULTS. THE EXTERNAL BALLOON WOULD DEFLATE SLIGHTLY FASTER WITHOUT THE CARTRIDGE ATTACHED, BUT STILL DID NOT DEFLATE AS QUICKLY AS MOST DEVICES, DEMONSTRATING THAT THE INVOLVEMENT OF THE CONSOLE WAS NOT A FACTOR. CLINICALLY, THIS WILL HAVE NO IMPACT. IN THE REPORTED CASE, IT WAS AN ANNOYANCE BECAUSE THE USER DECIDED TO DEFLATE THE BALLOONS AND REPOSITION AT THE START OF THE PROCEDURE. THE EXTERNAL BALLOON MADE VISUALIZATION DURING REPOSITIONING DIFFICULT (PER DISCUSSION WITH COOPER REPRESENTATIVE WHO WAS PRESENT). THE PROBE'S BALLOON INFLATION PATHWAYS CONSIST OF A POLYCARBONATE CONNECTOR ATTACHED TO A PEBAX LUMEN. THIS LUMEN PASSES UNDERNEATH THE BALLOON. A HOLE IS DRILLED IN THE LUMEN SO THAT IT CAN FILL AND EXHAUST THE BALLOON. BASED ON THE BEHAVIOR OF THIS PROBE, THIS PATH WAS FURTHER EXAMINED BY CUTTING THE BALLOON AWAY FROM THE SHAFT. IT WAS DISCOVERED THAT THE HOLE IN THE PEBAX LUMEN WAS NOT CLEAN-CUT AS INTENDED. SEE PICTURES BELOW COMPARING THE HOLE IN THIS DEVICE TO A TYPICAL DEVICE. WHILE THE INCOMPLETE HOLE ALLOWED FOR BALLOON INFLATION WHEN PRESSURIZED, IT RESTRICTED AIRFLOW DURING PASSIVE DEFLATION. BALLOON COMMUNICATION IS 100% VERIFIED IN MANUFACTURING THROUGH DIMENSION INSPECTIONS AND LEAK TESTING. THIS EXTERNAL BALLOON PASSED INFLATED LENGTH AND DIAMETER REQUIREMENTS AND AS WELL AS THE AUTOMATED LEAK TESTS. THERE IS NO DEFLATION REQUIREMENT FOR VAPOR PROBE BALLOONS BUT DEVICES WOULD BE IDENTIFIED AS MANUFACTURING REJECTS FOR BALLOONS THAT REMAIN INFLATED AND PREVENT SUBSEQUENT MANUFACTURING PROCESSES, WHICH DID NOT OCCUR WITH THIS UNIT. INVESTIGATION INTO THE MANUFACTURING HISTORY IS DESCRIBED ABOVE IN MANUFACTURING RECORD REVIEW SECTION. PROBE B: THE LAST USAGE STATE RECORDED ON THE EEPROM IS "INTEGRITY COMPLETE". THIS MEANS THE PROBE PASSED THE INTEGRITY TEST. THE USER THEN ELECTED TO DISCONTINUE USE OF THE PROBE BY PRESSING THE E-STOP BUTTON ONTHE CONSOLE WHICH TRIGGERS ALERT 199. IT IS REASONABLE TO CONCLUDE, BASED ON THE EEPROM STATE AND THE REPORTED COMPLAINT, THAT THE USER DID THIS BECAUSE THE PATENCY TEST DID NOT PASS. IF SO, THE REASON THE PATENCY TEST DID NOT PASS CANNOT BE ASCERTAINED FROM THE DEVICE INVESTIGATION. FUNCTIONAL TESTING WAS ALSO NOT POSSIBLE FOR THIS PROBE GIVEN THE STATE OF THE RETURNED DEVICE. REPORTED LACK OF BALLOON DEFLATION: THE SAME EVALUATIONS THAT WERE PERFORMED ON PROBE A WERE PERFORMED ON PROBE B. THE BALLOONS WERE BROUGHT UP TO USE PRESSURES AND WERE STABLE, PER DEVICE SPECIFICATIONS. VISUAL AND MANUAL MANIPULATION OF THE BALLOONS YIELDED SIMILAR CONCLUSIONS AS PROBE A. HOWEVER, PROBE B'S BALLOONS DEFLATED AT A NOTICEABLY FASTER RATE THAN PROBE A'S. CONCLUSION: REPORTED INTEGRITY AND PATENCY ISSUES COULD NOT BE CONFIRMED. BALLOON DEFLATION: THE PROBES PERFORMED PER SPECIFICATION. THE EXTERNAL BALLOONS WERE ABLE TO DEFLATE BUT THE DEFLATION RATE WAS SLOWER THAN TYPICAL. MANUAL COMPRESSION OF THE BALLOONS WAS HELPFUL IN DEFLATING THEM. ROOT CAUSE PATENCY: UNABLE TO CONFIRM. BALLOON DEFLATION: MANUFACTURING VARIABILITY (DEVICE DID MEET SPECIFICATION) CORRECTIVE ACTION: RETRAINING TO THE MLE SUB-ASSEMBLY HOLE DRILLING PROCESS (WI0074 REV 03 ON MAY 25, 2022 HAS BEEN COMPLETED. (NOTE THAT THE SUSPECTED ASSEMBLER THAT DRILLED THE COMPLAINT DEVICES IS NO LONGER WITH THE COMPANY.) FIRST OCCURRENCE; COOPERSURGICAL WILL CONTINUE TO TREND THIS FAILURE MODE.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT. MARA PROBES WOULD NOT PASS INTEGRITY/ PATENCY TESTS VAGINAL VAULT BALLOONS WOULD NOT DEFLATE WHICH WAS A PROBLEM W/ REPOSITIONING AND THE DOCTORS VIEW OF CERVIX. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING. PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? YES. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO. MEDICAL OR PROCEDURAL INTERVENTION? YES. PATIENT/GAMETE/EMBRYO STATUS : PATIENT IS FINE. MARA PROBE DDK-16-050 (B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT MARA PROBES WOULD NOT PASS INTEGRITY/ PATENCY TESTS VAGINAL VAULT BALLOONS WOULD NOT DEFLATE WHICH WAS A PROBLEM W/ REPOSITIONING AND THE DOCTORS VIEW OF CERVIX DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? YES ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO MEDICAL OR PROCEDURAL INTERVENTION? YES PATIENT/GAMETE/EMBRYO STATUS : PATIENT IS FINE ON 05/06/22 UPDATE_TELEPHONE CALL_2:41 PM_- PER FOLLOW-UP/ADDITIONAL INFORMATION. THE PROBES WOULD NOT PASS INTEGRITY/ PATENCY TESTS SO WE COULD NOT COMPLETE THE CASE. VAGINAL VAULT BALLOONS WOULD NEVER DEFLATE WHEN WE HAD TO REMOVE AND REPOSITION. MEDICAL OR PROCEDURAL INTERVENTION? YES. PATIENT WAS TAKEN TO OR TO GET THE ABLATION COMPLETED. PATIENT IS COMPLETELY FINE. PATIENT WAS NOT UNDER ANY FORM OF ANESTHESIA 1216677-2022-00146-1 MARA PROBE DDK-16-050 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309895 MARA PROBE MARA PROBE MNB COOPERSURGICAL, INC. DDK-16-050 21122301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other