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

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
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.During the procedure, the physician noticed that the needle was exposed while opening the implant package.It was reported that the device was not used, and the procedure was successfully completed with no patient harm or injury.Investigation of the returned device on (b)(6) 2023 confirmed that approximately.86mm of the needle tip was broken and unaccounted for.

• 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: elizabeth ashworth ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296525
• MDR Report Key: 17686783
• Report Number: 3015181082-2023-00035
• Device Sequence Number: 6032471
• Product Code: PEW
• UDI-Device Identifier: 10814932020299
• UDI-Public: 10814932020299
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/05/2023

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: IPN923352
• Device Lot Number: P02712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2023
• 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