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 09/01/2021

Event Type  Injury  

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 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
• 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: 12600531
• MDR Text Key: 277767223
• Report Number: 3011011193-2021-00020
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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): Required Intervention
• Patient Age: 48 YR