MAUDE Adverse Event Report: TELEFLEX INCORPORATED UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Model Number	IPN924185
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the urolift procedure, surgeon went to place implant and the handle was squeezed but not deployed.According to the surgeon, the handle was not cutting the tab and the surgeon felt the handle was malfunctioning.Another urolift handle was opened and the remaining implants were placed without any problems.The procedure was completed without any harm to the patient.

• Brand Name: UROLIFT
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18181599
• Report Number: 18181599
• Device Sequence Number: 7717018
• Product Code: PEW
• UDI-Device Identifier: 20814932020357
• UDI-Public: (01)20814932020357(17)250627(10)73F2301006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2023
• Report Date (Section F): 11/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN924185
• Device Catalogue Number: UL2-CHK
• Device Lot Number: 73F2301006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White
• Date Report Sent to FDA: 11/06/2023