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

Model Number	7100
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.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 during an acessa procedure on (b)(6) 2025, the physician reported that half-way through the procedure, an error was observed in the console.Customer powered down the console and restarted it but issue did not clear, pads and cables were replaced but that did not fix the issue.The procedure at this point was aborted.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation: the reported complaint describes that the system was displaying "error: rf output ended, high pad contact resistance" during a procedure that could not be cleared.To test for this failure, the console was powered on and all accessories were connected to perform the ablation and coagulation tests.Here, it was observed that the console functioned as intended during coagulation.However, two seconds into ablation at around 6 to 11 watts, the system displayed the "error: rf output ended, high pad contact resistance" as shown in the file attached.Hence, the failure mode reported by the customer was replicated during investigation.An external visual inspection was conducted and there were damages to the front panel and cover.To further investigate the reported failure, the cover was removed to visually inspect the dpi board for any internal connection issues.Here, it was observed that there was an impact damage to the bracket in between the board as shown in the file attached.After evaluation, it was determined that the reported issue is likely caused by an electrical issue with the dpi board.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 22459850
• Report Number: 1222780-2025-00371
• Device Sequence Number: 8079076
• Product Code: HFG
• UDI-Device Identifier: 00854763006232
• UDI-Public: (01)00854763006232(11)221219
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7100
• Device Catalogue Number: 7100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2022
• 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
• Patient Sex: Unknown