MAUDE Adverse Event Report: COOPERSURGICAL, INC. MARA WATER VAPOR PROBE KIT; WATER VAPOUR ENDOMETRIAL-ABLATION APPLICATOR

Model Number	DDK-16-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an ablation procedure on (b)(6) 2023.Patient experienced severe burning of the uterine lining, per the pathology report, that required laparoscopy.An emergency hysterectomy was performed 2-3 days post procedure.To note, this patient apparently was told by another physician that her uterine cavity was too narrow for a novasure procedure ( a different type of uterine ablation device).No additional information is available.Ddk-16-050 mara (b)(4).
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
D4: lot #: unknown.Expiration date: unknown.H4: manufacturing date: unknown.Manufacturing record review: review of records could not be performed as the reported lot number was incorrect.The lot number reported and the fiso serial number recorded in the provided case telemetry files do not match as this fiso serial number is not recorded in (b)(4).This indicates that the wrong lot number was reported.Incoming inspection review: not applicable - this is a manufactured device, not a purchased device.Service history record: not applicable - this device is non-serviceable.Historical complaint review: the complaint occurrence rate for burns is 4.Per the november mara trending report.Product receipt: the complaint unit was not returned to csi.Visual evaluation: n/a- device was not returned.Functional evaluation: n/a- device was not returned.Console telemetry review: telemetry files, from the console used during the procedure were collected.A review and analysis of the of the telemetry files, shows the probe self-test, integrity/patency and treatment passed successfully.Conclusion: case telemetry of the probe used during the procedure, retrieved from the console, shows the cervical thermocouple temperature started at a temperature of 30.66c and increased to a max of 40.09c which in the normal range.Average intrauterine pressure throughout treatment was within normal range at 47.24 mmhg.There were no alerts recorded.Based on the case telemetry there is no indication of a device malfunction.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h11.Correction: g1.No change to the final investigation findings.Updating the udi number.Correction to email contact.
Event or Problem Description
No additional information.

• Brand Name: MARA WATER VAPOR PROBE KIT
• Common Device Name: WATER VAPOUR ENDOMETRIAL-ABLATION APPLICATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 18084781
• Report Number: 1216677-2023-00154
• Device Sequence Number: 20480871
• Product Code: MNB
• UDI-Device Identifier: 00888937026887
• UDI-Public: (01)00888937026887
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: DDK-16-050
• Device Catalogue Number: DDK-16-050
• Device Lot Number: M-220314-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 10/25/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/19/2023; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female