MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400

Model Number UL400

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2020

Event Type  malfunction  

Event Description

On 14 feb 2020, neotract was informed of a prostatic urethral lift (pul) procedure during which the physician noted that several devices appeared to have capsular tab pull-throughs and bone strikes.No patient harm or injury was reported.On 31 mar 2020, neotract's investigation of the returned devices indicated that two devices were missing 1-2mm of the needle tip (this report is for device 1 of 2).Neotract notified the physician of the investigation results.On (b)(6) 2020, the physician acknowledged the missing needle piece and stated that the patient did have a ct scan on (b)(6) 2020 and saw nothing concerning on the scan.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard rd.; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10006602
• MDR Text Key: 194182009
• Report Number: 3005791775-2020-00022
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2020

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
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00155
• Device Lot Number: P42792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1