MAUDE Adverse Event Report: COOPERSURGICAL, INC. MARA CONSOLE

Model Number	GEN-16-050
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported condition is currently being investigated.
Event or Problem Description
Incident details surrounding event "would not pass patency, no movement on console gauge" "procedure not completed." "in-office under general anesthesia." "the dr decided to reschedule her procedure to be done in the or at a later date." mara console gen-16-050 (b)(4).
Event or Problem Description
Incident details surrounding event: "would not pass patency, no movement on console gauge.Procedure not completed." "in-office under general anesthesia.The dr decided to reschedule her procedure to be done in the or at a later date." 1216677-2022-00343 mara console gen-16-050 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation x-no sample returned analysis and findings e-complaint-(b)(4).Was the complaint confirmed? no.Distribution history the complaint unit was purchased from aegea medical, by csi on 02-07-22, shipped on 08-05-22.Manufacturing record review a review of the device history record could not be performed as the record could not be located at the time of this investigation.If the dhr should be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review the aegea incoming console - aegq-2121 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record no prior service history record was found for this unit.Historical complaint review a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt the complaint unit has not been returned to coopersurgical.Visual evaluation an evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation an evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical, also, telemetry data has not been received.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action complaint unit has not been returned to coopersurgical so the complaint could not be confirmed.Coopersurgical will continue to trend this complaint condition.No further corrective actions necessary.No further training is required since the complaint was not confirmed.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
Additional Manufacturer Narrative
Clarification to h6 component code: unit is a mara console, and the part that had the alleged malfunction was not identifiable by the customer nor the technicians evaluating the device.Device evaluation: the complaint unit was returned on 01/mar/2023.An evaluation of the complaint product revealed no physical damage.A functional evaluation of the product showed no problems.The console went through three tests, passed eached one, and the hardware was functional.Root cause: root cause is not applicable as the complaint condition was not confirmed.Corrective actions: the unit was evaluated and found to meet qa specifications.It is being restocked as a demo.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
Healthcare professional reported via company representative "would not pass patency, no movement on console gauge," and the procedure was not completed.

• Brand Name: MARA CONSOLE
• Common Device Name: MARA CONSOLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 95 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16159109
• Report Number: 1216677-2022-00343
• Device Sequence Number: 18021407
• Product Code: MNB
• UDI-Device Identifier: 00857379006023
• UDI-Public: 00857379006023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2023

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 Model Number: GEN-16-050
• Device Catalogue Number: GEN-16-050
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 12/13/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/17/2023; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female