MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure that day.During the procedure, it was noted that one device did not properly deploy the implant.The case was aborted.It was reported that the patient experienced bleeding which was controlled using a monopolar electrode, and a catheter was placed.Investigation of the returned device on (b)(6) 2023 noted that a fragment of a broken scope seal was returned.The other portion of the broken scope seal was not returned; therefore, it is unable to be determined if there is a missing fragment(s).The physician was notified and reported that the patient is doing fine and he will continue to see the patient regularly to ensure that the patient continues to do well.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: kathleen shin ; 4155 hopyard road; pleasanton, CA 94588 ; 9252080692
• MDR Report Key: 16707608
• Report Number: 3015181082-2023-00026
• Device Sequence Number: 3614906
• Product Code: PEW
• UDI-Device Identifier: 10814932020282
• UDI-Public: 10814932020282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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 Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN923351
• Device Lot Number: P02574
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male