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

Model Number	7300
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acessa procedure on (b)(6) 2024 while the physician was performing the procedure, he ablated a fibroid and realized that one of the needles didn´t seem fully seated.The handpiece was deployed outside the patient and noticed that two tips were shorter that the rest of the others.One of the needle tips was found stuck to the side of the ultrasound probe, the physician used graspers to remove it.Post procedure the physician thought that maybe the other tip was inside a fibroid.Physician reported that no additional medical intervention required.No other information 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.Manufacture date and expiration date not available at the time of this report a follow up email will follow with the information.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
Udi additional information included.Please refer to section d.
Additional Manufacturer Narrative
The device was returned for investigation: visual inspection was conducted, and it was found that five thermocouples were bent and the remaining two were broken.Functional testing was not conducted since the issue could be confirmed during the visual inspection.Hence, the complaint can 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.Additional information was received related to the case: prior to the device being used there was no interaction with other instruments, it is not know if the device was inspected prior to use.The physician commented that as he deployed the needles it noted that it was tough.Ablation was completed and as they started to coagulate out they paused as the physician had not pulled back on the purple ring to undeploy the needle arrays.The physician felt as it was sticking but was able to pull the ring back and coagulate out of the patient.They reviewed the abdomen and near the uterus via laparoscopic camera and did not locate any piece of the needle.No other information available.

• 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: 21036172
• Report Number: 1222780-2024-00508
• Device Sequence Number: 7656456
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: (01)00854763006140(10)C001835701(17)260312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/20/2025

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: 03/12/2026
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Device Lot Number: C001835701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: Not provided; 01/22/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/16/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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