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

Lot Number P39570

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

When urolift was fired, the clip flew off.The surgeon was able to retrieve and remove it from the body.Unk if operator error or device malfunction.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: UROLIFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.
• MDR Report Key: 8869312
• MDR Text Key: 153850086
• Report Number: MW5088861
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Lot Number: P39570
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR