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

Model Number	UL400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On 10 jan 2020, neotract was informed of successful prostatic urethral lift (pul) procedure during which a delivery device did not deployed properly, there was no patient injury or harm reported, and the device was returned for investigation.On 04 feb 2020, neotract's device analysis confirmed that a 1 -2mm needle tip was missing from the returned device.Neotract had notified the physician of the missing needle tip.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• MDR Report Key: 9793193
• Report Number: 3005791775-2020-00014
• Device Sequence Number: 19621490
• Product Code: PEW
• UDI-Device Identifier: 00814932020049
• UDI-Public: 00814932020049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: UL400
• Device Catalogue Number: AN00136
• Device Lot Number: 73L1900620/2776920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1