MAUDE Adverse Event Report: COOPERSURGICAL, INC. MARA PROBE; 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	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown, customer has indicated that the device will not be returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a mara ablation procedure on (b)(6) 2024.Five weeks post procedure, the patient underwent a hysterectomy due to a significant uterine infection.Doctor unsure if the infection is related to the mara procedure.No additional information is available.Ddk-16-050 mara probe (b)(4).
Additional Manufacturer Narrative
Manufacturing record review: records for lot m-220729-06 (w/o (b)(4)) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the complaint data reveals one complaint involving a mara treatment.The patient suffered a burn and developed a vaginal infection diagnosed as bacterial vaginitis.However, in this case, no burns were reported.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause: no definitive root cause for this issue could be reliably determined at this time, the product was not returned for evaluation and no further evidence to support the complaint condition was provided.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information is available.

• Brand Name: MARA PROBE
• 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: 19519438
• Report Number: 1216677-2024-00026
• Device Sequence Number: 8540808
• Product Code: MNB
• UDI-Device Identifier: 00888937026887
• UDI-Public: (01)00888937026887
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 09/30/2024
• Device Model Number: DDK-16-050
• Device Catalogue Number: DDK-16-050
• Device Lot Number: M-220921-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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