MAUDE Adverse Event Report: HOLOGIC, INC ACESSA PROVU SYSTEM; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number	7300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that the patient was admitted for pain 10 days post acessa procedure.The procedure was completed with no complications.There was no bleeding but a lot of fibroids.Patient went home that day with no issues.Per a clinical discussion the patient is a 42-year-old who had four to five fibroids that were treated.These were approximately in the 4-centimeter range with multiple applications of radio frequency energy.The patient returned to the hospital emergency room approximately 10 days later complaining of pain ct scan showed a 3.5 cm defect in the anterior myometrium comparable to coagulative necrosis.There was no free fluid, and there was some question as to whether this defect communicated with the endometrial cavity.The white blood count was normal, and the patient remained stable with no rebound tenderness.There was no evidence of infection and antibiotics were not started.After 2 days in the hospital, the patient was improving and feeling better and was discharged home.Prophylactic antibiotics were not used.No concomitant procedures were done.Discussion of the use of prophylactic antibiotics in the clinical trial occurred and noted this may be reasonable to consider for future cases.The patient was low risk for pelvic infection and was monogamous relationship.Discussion on the appearance of the fibroids on ct scan and ultrasound in the immediate time period was done following the procedure and how this might appear unusual to most radiologists unless they have extensive experience dealing with post assessor patients.The uterus in general is boggy and soft and that the first menstrual period might be quite heavy and the instrumentation should be avoided because of the increased risk of perforation.

• Brand Name: ACESSA PROVU SYSTEM
• Common Device Name: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 23976797
• Report Number: 1222780-2026-00008
• Device Sequence Number: 4554150
• Product Code: HFG
• UDI-Device Identifier: 15420045515246
• UDI-Public: 15420045515246
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: 7300
• Device Catalogue Number: 7300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Other
• Patient Sex: Unknown