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

Model Number	7100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The provu console was evaluated by pmqa on august 30, 2022.A visual inspection was completed with no obvious signs of damage or misuse.Provu console 000071 was powered on with no issues noted.Upon investigation, there were no issues regarding the 3d guidance or error message reading tracking configuration.Additionally, using the foot pedal from the procedure and the foot pedal from pmqa, there were no issues regarding foot pedal function for ablation and coagulation activation.The reported complaint has not been confirmed.There was no fault found upon evaluation and the device met the manufacturer´s specifications.Hologic will continue to track and trend this failure mode, should an adverse trend arise further action will be taken.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.
Event or Problem Description
It was reported that during an acessa procedure on august 9th, before the procedure there was a power surge at the facility which caused the console to power off.When the power came back on the console was attempted to be used and could not perform ablation or coagulation.The physician decided to abort the procedure.The patient had already been placed under anesthesia and with the trocars on.No other information is available.

• 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 zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15392058
• Report Number: 1222780-2022-00244
• Device Sequence Number: 20377998
• Product Code: HFG
• UDI-Device Identifier: 00854763006232
• UDI-Public: 00854763006232
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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 Model Number: 7100
• Device Catalogue Number: 7100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female