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

Model Number M006580210

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

A lot history review was performed for genesys hta procedural set lot# 26499926 dhr review did not reveal any non-conformity during manufacturing.There was no other complaint reported against genesys hta procedural set lot# 26499926.90882082-01a genesys hta operator manual section 2.2 informs the user that the procedure is contraindicated in patients "in whom a tight cervical seal cannot be established and maintained around the procedure sheath." black box warning in section 2.3 warns the user that "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." section 2.3.2 warns the user that "once heating has begun maintain a stable sheath position and do not remove the procedure sheath until the post-treatment cooling cycle has been completed as confirmed by the display screen, as heated fluid may cause thermal injury to the patient." section 2.3 cautions the user that "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." reasonable attempts have been made to retrieve the involved devices for investigation.However, the procedural set was disposed of after the procedure.Physical product examination is not possible.Unable to develop a direct relationship of the device to the reported adverse event.There is no allegation of a device malfunction.

Event Description

It was reported that a genesys hta procerva procedure set was used in a procedure.During the procedure a fluid loss alarm was declared approximately 2 minutes into the ablation cycle.Dr.Attempted to seal the cervix using an additional tenaculum.During this attempt, an additional volume of intra-cavitary (previously heated) fluid escaped from the uterine cavity and spilled onto patient's vaginal mucosa and perineum, inflicting unintended thermal effect on these structures.The thermal damage was graded as second degree and was managed with topical silvadene cream as well as referral to a specialist.

• Brand Name: HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
• Type of Device: THERMAL ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer (Section G): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer Contact: veronica williams ; 4255 burton drive; santa clara, CA 95054 ; 6503991771
• MDR Report Key: 11609061
• MDR Text Key: 243616986
• Report Number: 3011011193-2021-00003
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2022
• Device Model Number: M006580210
• Device Catalogue Number: M006580210
• Device Lot Number: 26499926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other