MAUDE Adverse Event Report: SURGENTEC, LLC ALARA NEURO ACCESS NEEDLE; NERVE STIMULATOR / LOCATOR

Catalog Number	PS-09-2NS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rep sent in a usage sheet that showed expired product was used in the case.The date of the case was april 8th, 2025 and the product expired on march 31st, 2025.No patient harm was reported and the patient was not under anesthesia longer than originally anticipated.We did notify the rep on 3/11/25 that the product was about to expire and requested for it to be returned.

• Brand Name: ALARA NEURO ACCESS NEEDLE
• Common Device Name: NERVE STIMULATOR / LOCATOR
• Manufacturer (Section D): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer (Section G): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: guilherme pires ; 911 clint moore rd; boca raton, FL 33487 ; 5619907882
• MDR Report Key: 22019294
• Report Number: 3012495575-2025-00004
• Device Sequence Number: 9390892
• Product Code: PDQ
• UDI-Device Identifier: 00858406007303
• UDI-Public: 00858406007303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 03/31/2025
• Device Catalogue Number: PS-09-2NS
• Device Lot Number: 22SUR0282
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown