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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acessa procedure on (b)96) 2024, the coagulation function was not burning correctly and the puncture site continued to bleed.The bleeding was from the fibroid being treated and the amount of blood could not be specified.Bleeding was stopped with a separate monopolar instrument.The procedure was completed and the patient was doing fine.No other additional intervention was required.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) unavailable at the time of this report.A follow up will follow with the information when available.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 for investigation: visual inspection was conducted, and there were no signs of physical damage.Functional testing was conducted, and there is electrical continuity between the distal mandrel and the rf pin.Additionally, the ablation and coagulation were compared with an "engineering for use" unit and the performance of both disposables was consistent, even the temperature during the coagulation was reviewed, and everything worked as intended.Additionally, a dissection test was conducted and all the internal components were in good condition, nothing abnormal was observed.Hence the complaint cannot be confirmed.This observation will be monitored and trended.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: 20870099
• Report Number: 1222780-2024-00465
• Device Sequence Number: 8592517
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)C002255701(17)260912
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/06/2025

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 Expiration Date: 09/12/2026
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Device Lot Number: C002255701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown