MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On january 28, 2025, neotract has been made aware that ¿a 72 year old male patient with a 36 gram prostate and no known pre-existing urological conditions, underwent an in-office procedure that was performed under a prostate block and nitrous gas.During the first implant attempt, the physician followed the standard technique, starting at the bladder neck, angling the handle at 10 o¿clock with 5¿10 degrees of compression, and pulling the trigger three times, but no suture was visible in the keyhole.Following guidance, he withdrew the device and performed the fourth pull on the side table, but no implant was released.The back of the cartridge was checked, and no buckle was found.A second attempt with a new cartridge followed the same steps, yielding the same result.A third attempt with a new handle, with careful hand movements, also failed.Observing both the physician¿s hands and the screen, the representative confirmed proper technique was followed.After aborting the procedure, an investigation on the side table showed that all three cartridge indicators were recessed as if an implant had been placed.When running through the four trigger pulls on spent cartridges, the capsular tab and implant became visible.Two cartridges still contained implants, suggesting misfires during the procedure despite the physician not using spent devices.No patient harm or injury was reported, but the procedure was aborted, leaving the patient untreated.¿ additional information received on march 04, 2025, indicated that ¿both handles and all cartridges involved will be returned for evaluation.¿.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316, rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no.1316, rancho el descanso; tecate ; MX
• Manufacturer Contact: laura gonzalez serrano ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 21732112
• Report Number: 3015181082-2025-00044
• Device Sequence Number: 11817979
• Product Code: PEW
• UDI-Device Identifier: 10814932020350
• UDI-Public: 10814932020350
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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 Expiration Date: 06/12/2026
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN924185
• Device Lot Number: 73F2400525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Black Or African American