MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT ADVANCED TISSUE CONTROL SYSTEM; UROLIFT ATC SYSTEM

Model Number UROLIFT ATC SYSTEM

Device Problem Fracture (1260)

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

Event Date 08/17/2020

Event Type  malfunction  

Event Description

On 17 august 2020, neotract was informed of a prostatic urethral lift (pul) procedure during which the physician noted that a device appeared to not deploy properly.The procedure was completed successfully and no patient harm or injury was reported.On 2 september 2020, neotract's investigation of the returned device indicated that it was missing 1-2mm of the needle tip.Neotract notified the physician of the investigation results who, on (b)(6) 2020, acknowledged the missing needle piece and stated that he did not feel further evaluation was warranted.

• Brand Name: NEOTRACT UROLIFT ADVANCED TISSUE CONTROL SYSTEM
• Type of Device: UROLIFT ATC 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: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10621527
• MDR Text Key: 209641597
• Report Number: 3005791775-2020-00046
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020145
• UDI-Public: 10814932020145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200441
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UROLIFT ATC SYSTEM
• Device Catalogue Number: UL400-ATC
• Device Lot Number: P44288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• 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