MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Model Number UL400-4

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

The device did not fire correctly.No patient harm.

• Brand Name: UROLIFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4473 willow road ste 100; pleasanton CA 94588
• MDR Report Key: 8594767
• MDR Text Key: 144544746
• Report Number: 8594767
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: (01)00814932020001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UL400-4
• Device Catalogue Number: UL400-4
• Device Lot Number: P40579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA