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

Model Number	7100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acessa procedure on (b)(6) 2025, there a tabletop generator indicator (ttfg) that would not stay on after the ttfg was plugged into the system.The staff checked the ttfg cable and the ttfg placement and confirmed both were correct.The system power cycled and an error was receieved when it powered back on that stated guidance failure, no tracker and there was no green check on screen to indicate the ttfg was connected.The system power cycled multiple times and the ttfg cable was unplugged and re-plugged from both the system and the ttfg which did not resolve.The physician chose to abort the procedure where no 3d guidance could be used.After testing the system on site with additional equipment, it was discovered that the issue was with the generator.The testing successfully connected the ttfg to the uui system with the same ttfg cable with no errors and connection issues.The system worked as intended after switching the console.No other information is available.
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.
Additional Manufacturer Narrative
Device was returned: external visual inspection noted no signs of damage or misuse on the console.The console could not pass the boot screen and was not responsive.An attempt was made to power cycle the console, but the error could not be bypassed.The ablation and coagulation test could not be conducted due to the console not responding to multiple attempts.The console was unresponsive.The reported issue could not be tested due to this reason.A software issue was identified.

• Brand Name: PROVU CONSOLE ASSEMBLY
• 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: 23977054
• Report Number: 1222780-2026-00010
• Device Sequence Number: 14609988
• Product Code: HFG
• UDI-Device Identifier: 15420045515307
• UDI-Public: (01)15420045515307(11)190814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2026

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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• 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