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

Model Number 7100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Console returned for investigational purposes : a visual inspection was completed with no signs of damage or misuse.Provu console (b)(6) was powered on with no issues noted.When plugging in the hdmi cable into the console, there were no issues regarding the hdmi port being loose, it is stable.Once the handpiece was connected, its deployment value was shown as 0 cm when retracted and displayed the correct values when deployed further.Additionally, there were no issues noted with the foot pedal function; the console ablated up to 200 w with the handpiece deployed at 1 cm and coagulated for 10 seconds with the handpiece fully retracted, it functioned as intended.The reported complaint has not been confirmed.There was no fault found upon evaluation.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 Description

It was reported that during an acessa procedure on (b)(4), 2023.The physician experienced issues with the foot pedal and could not activate the ablation.Due to the issues experienced with the console the procedure had to be aborted, the trocars had already been placed.No patient injury reported.

• Brand Name: ACESSA PROVU SYSTEM
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA
• 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: 18325871
• MDR Text Key: 330493004
• Report Number: 1222780-2023-00463
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 15420045515307
• UDI-Public: (01)15420045515307(11)211020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2023

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
• Device Operator: Health Professional
• Device Model Number: 7100
• Device Catalogue Number: 7100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other