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

Model Number	7300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acessa procedure on (b)(6) 2025, the customer reported that after the 6th ablation and while the device was still in the patient the physician could not deploy the needles of the handpiece as the slider know was stuck and could not deploy.The device was removed from the patient and a second device was used to complete the procedure.When the device was returned for investigation it was observed that in 2 needles the tip was missing and broken, the other 5 were bent.No other information available.
Additional Manufacturer Narrative
Additional information is being requested from the customer.Device history record (dhr) review was unable to be conducted for the disposable device at the time of this report a follow up report will follow with the information from the dhr.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, the unit was properly packaged inside the biohazard kit, and 3 bags that prevented it from getting damaged.Acessa handpiece was also reviewed, and the shaft was slightly bent.Functional testing was conducted, and the purple ring could not be moved (forward and backward).Disposable was opened to review internal components, and no issues were found regarding the purple ring and its mechanism.The distal tip of the shaft cover was removed with a cutter to confirm the presence of all the needles.At this time, it was found that the tips of 2 needles were missing, the bag was examined and no trace of the broken needles was found.The distal mandrel was removed in order to deploy the needles and review their integrity.2 needles were broken, and the remaining 5 were bent.Additionally, the needle tracks located on the distal mandrel were twisted.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 HANDPIECE
• 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: 22061354
• Report Number: 1222780-2025-00269
• Device Sequence Number: 18052050
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)C001974101(17)260524
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/08/2025

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 Expiration Date: 05/24/2026
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Device Lot Number: C001974101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: Other
• Patient Sex: Unknown