MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM; 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	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
90882082-01a genesys hta dfu 2.3.3 cautions advise the user to "confirm that the vaginal speculum is an adequate size (width and length) to assure full separation of vaginal and vulvar tissue away from the procedure sheath, to avoid inadvertent thermal injury, and to provide visibility of the cervix.The temperature of the sheath at this location could be up to 65°c".The procedure set was disposed of after the procedure.Physical product examination is not possible.
Event or Problem Description
During the procedure a fluid loss alarm was declared 3 minutes into the ablation cycle.Doctor did not see any evidence fluid leak.After the third alarm doctor chose to abort the procedure.Doctor noticed one small area of unintended thermal effect on posterior vaginal mucosa, which was treated with vaginal cream (exact brand unknown) and a similar size area on perineum, which was treated topically with silvadene cream.Patient discharged the same day.

• Brand Name: MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 12478623
• Report Number: 3011011193-2021-00016
• Device Sequence Number: 3892013
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 08/19/2021
• 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