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

Model Number UL2C

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

The urolift implant device did not deploy its implant cartridge, device was not implanted.

Event Description

Additional information received for report mw5120341 on 08/29/2023 for update to manufacturer.

• Brand Name: UROLIFT CARTRIDGE
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): TELEFLEX/ NEOTRACT, INC.
• MDR Report Key: 17424725
• MDR Text Key: 320174662
• Report Number: MW5120341
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: UL2C
• Device Lot Number: 73C2300238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male