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

Model Number	7300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
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 when he attempted to retract the handpiece from the patient´s fibroid, one of the needles stayed inside the fibroid and was sticking out of the top of the fibroid.Once the physician removed the whole handpiece from the patient, he removed the stuck needle and notice that the tip of the device was missing.After taking a closer look at the fibroid inside the patient the tip was seen wedged inside the top of the fibroid.The physician was able to remove the entirely of the tip that was wedged on top of the fibroid and no harm was reported to the patient.No additional intervention was required and the procedure was completed using a second device.The pieces were set aside and prepared to be returned to the manufacturer.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted; the distal mandrel and the detached needles were returned in a box.The distal mandrel, the needle that got detached, and the remaining 6 needles that were still attached to the handpiece were all bent.The welded sections on the distal mandrel were intact with no gaps or irregularities identified.In addition, the needle that got detached was further reviewed, and after disassembling the handpiece shaft, it was confirmed that the needle was damaged/bent within the shaft.Functional testing was not conducted because the issues found during the visual inspection did not allow the disposable to be functionally reviewed.However, based on the evidence found the problem reported by the customer could be confirmed.This observation will be monitored and trended.

• 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: 22309253
• Report Number: 1222780-2025-00335
• Device Sequence Number: 7937405
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)C002272701(17)260923
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 09/23/2026
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Device Lot Number: C002272701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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