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

Model Number	M006580210
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The warnings section for genesys hta states: "leakage of heated fluid can cause serious burn or injury to the tissue contacted, including tissue in or around the cervix, vagina, perineum, etc.Failure to follow instructions or to heed any warnings or cautions could result in serious patient or user injury"."the physician must maintain control of the procedure sheath (i.E., not hand off to another individual) for the duration of the treatment to avoid compromising the cervical seal.A compromise of the cervical seal could result in fluid leakage through the cervix, which could result in thermal injury to surrounding tissue"."throughout the procedure, carefully observe the junction of the procedure sheath with the external cervical os to confirm a tight cervical seal and that there is no fluid leakage".The procedure set was reportedly discarded and was not returned for evaluation.A review of the procedure set history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that during an hta procedure performed in a (b)(6) year-old patient suffering from aub, hot fluid leaked resulting in a second-degree unintended thermal effect on her buttock.The patient is currently undergoing treatment for this adverse event which involves debridement with flap.

• 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: 12600531
• Report Number: 3011011193-2021-00020
• Device Sequence Number: 11768210
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/08/2021

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 Expiration Date: 03/25/2023
• Device Model Number: M006580210
• Device Catalogue Number: M006580211
• Device Lot Number: 27134240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: Required Intervention
• Patient Age: 48 YR