MAUDE Adverse Event Report: MINERVA SURGICAL, INC. GENESYS HTA PROCERVA PROCEDURAL SET; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	M006580210
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an hta procedure was performed on patient suffering from aub (e).The patient was actively bleeding at the time of the operative visit.During the diagnostic hysteroscopy (not ablation) phase, the physician experienced leaks at the cervix three times, necessitating placement of four instruments on the cervix to achieve a cervical seal.The ablation cycle was completed successfully.During the cooling phase, one of the four instruments, used to create the cervical seal, was removed from the cervix.This resulted in heated intra-cavitary fluid migration from the uterine cavity and into the vagina, resulting in an unintended thermal effect on vaginal mucosa.The physician treated the affected area with a cool saline gauze and silver sulfadiazine topical cream.
Additional Manufacturer Narrative
Manufacturer contacted the physician to obtain additional information related to this event.The physician is fully aware of the steps of the procedure and the risks associated with the use of the device.The removal of the instruments during the cooling phase resulted in a compromised cervical seal which caused the heated fluid to leak at the cervix.It was acknowledged by the physician that the additional instruments used to create the cervical seal should not have been removed during the cooling phase.The physician checked in with the patient twice within the days following the event and reported the patient is doing well and experienced only mild discomfort.No additional medical intervention, beyond the application of the topical cream, was required.The ifu instructs the user to monitor the cervical seal for fluid loss and to confirm a tight cervical seal is maintained.The user is instructed to release the tenaculum stabilizer only once the system has detected proper cooling (<45°c) has occurred.Warnings and cautions related to an event of this nature are included in the ifu for genesys hta, including but not limited to: "warning: once heating has begun do not remove the procedure sheath until the post-treatment cooling cycle has been completed, as heated fluid may cause thermal injury to the patient." "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 discarded and was not returned for evaluation.The lot number of the procedure set was not provided, therefore a device history record review could not be performed.However, all surgical procedure sets meet all qa specifications when released, including adequate sterilization.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
Manufacturer contacted the physician to obtain additional information related to this event.The physician is fully aware of the steps of the procedure and the risks associated with the use of the device.The removal of the instruments during the cooling phase resulted in a compromised cervical seal which caused the heated fluid to leak at the cervix.It was acknowledged by the physician that the additional instruments used to create the cervical seal should not have been removed during the cooling phase.The physician checked in with the patient twice within the days following the event and reported the patient is doing well and experienced only mild discomfort.No additional medical intervention, beyond the application of the topical cream, was required.The ifu instructs the user to monitor the cervical seal for fluid loss and to confirm a tight cervical seal is maintained.The user is instructed to release the tenaculum stabilizer only once the system has detected proper cooling (<45°c) has occurred.Warnings and cautions related to an event of this nature are included in the ifu for genesys hta, including but not limited to: "warning: once heating has begun do not remove the procedure sheath until the post-treatment cooling cycle has been completed, as heated fluid may cause thermal injury to the patient." "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 discarded and was not returned for evaluation.The lot number of the procedure set was not provided, therefore a device history record review could not be performed.However, all surgical procedure sets meet all qa specifications when released, including adequate sterilization.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that an hta procedure was performed on patient suffering from aub (e).The patient was actively bleeding at the time of the operative visit.During the diagnostic hysteroscopy (not ablation) phase, the physician experienced leaks at the cervix three times, necessitating placement of four instruments on the cervix to achieve a cervical seal.The ablation cycle was completed successfully.During the cooling phase, one of the four instruments, used to create the cervical seal, was removed from the cervix.This resulted in heated intra-cavitary fluid migration from the uterine cavity and into the vagina, resulting in an unintended thermal effect on vaginal mucosa.The physician treated the affected area with a cool saline gauze and silver sulfadiazine topical cream.

• Brand Name: GENESYS HTA PROCERVA PROCEDURAL SET
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• 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: 13601664
• Report Number: 3011011193-2022-00003
• Device Sequence Number: 16608541
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: (01)08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female