MAUDE Adverse Event Report: MINERVA SURGICAL INC HTA HYSTEROSCOPE ADAPTER, STORZ

Catalog Number	M006550310
Medical Device Problem Codes	Degraded (1153); Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Minerva surgical has attempted to obtain additional information from the facility with limited success.Based on the available information, it has been determined that the potential cause of the event was due to the malfunction of an hta adapter, a genesys hta accessory, that has been in use at the facility since 2005.The adapter has been used well past its intended life and recommended reprocessing cycles.It is suspected the wear and degradation of the 2005 adapter caused leaking which ultimately led to the reported burn.The hta adapter used in this case was not returned and therefore a failure analysis of the complaint device could not be performed.Due to the age of the device (circa 2005), the lot number being unknown, and the device not manufactured by minerva surgical; a device history review could not be performed.A risk review was performed.The risk of a minor burn is associated with a leaking adapter caused by material degradation.The genesys hta system's user manual provides guidance and steps for proper cleaning and sterilization and states the adapter may be reused/resterilized up to 40 times.The minerva surgical representative was not present for the case but followed up with the facility and performed an in-service and product education on january 19th, 2024.Minerva surgical was not made aware of any medical intervention.It was reported the facility discarded all adapters from 2005 and it has been confirmed the facility ordered replacements.
Event or Problem Description
Boston scientific complaint department forwarded a medwatch report, 2302300000-2024-8002, to the minerva surgical complaint department on march 21st, 2024.The medwatch report stated "patient presented to the operating room (or) for a planned dilation and curettage (d&c), hydrothermal ablation (hta) procedure.During the surgery, the hta equipment failed, allowing the scope to become incredibly hot and burned this patient's vaginal opening and cervix.We learned that the wolf hysteroscope adapter was supposed to be replaced at every 40 uses which we did not do.We have discarded all of our supplies from 2005 and have ordered all new ones.".

• Brand Name: HTA HYSTEROSCOPE ADAPTER, STORZ
• Common Device Name: HYSTEROSCOPE ADAPTER
• 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: michelle becker ; 4255 burton drive; santa clara, CA 95054 ; 9787601704
• MDR Report Key: 19050595
• Report Number: 3011011193-2024-00006
• Device Sequence Number: 7270716
• Product Code: NWW
• UDI-Device Identifier: 08714729469773
• UDI-Public: 08714729469773
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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 Catalogue Number: M006550310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female