MAUDE Adverse Event Report: MINERVA SURGICAL, INC. HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM; THERMAL ENDOMETRIAL ABLATION DEVICE

Model Number	M006580210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the procedure set was not provided, therefore a device history record review could not be performed.The procedure set was disposed of after the procedure.Physical product examination is not possible.The warnings section of the genesys hta dfu states: do not place the procedure sheath tubing over patient's leg or in contact with any part of the user's or patient's anatomy, as the tubing carries hot fluid and contact could result in thermal injury.The temperature of the tubing could be up to 55c.
Event or Problem Description
Doctor reported that an hta procedure was performed in an approximately (b)(6) patient suffering from aub.The patient was also suffering from diabetes and epilepsy.No alarms or leaks were present; however the procedure sheath tubing was in contact with the patient's buttock during the ablation cycle.Upon completion of the procedure, doctor noticed a quarter size area of unintended thermal effect on the area of contact between the buttock and the procedure sheath tubing, which was treated with silvadene cream.Patient was discharged.

• Brand Name: HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: THERMAL ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 12478592
• Report Number: 3011011193-2021-00017
• Device Sequence Number: 3892012
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR