MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PROSTATE STABILIZATION SET 18GA X 20CM; SYSTEM, APPLICATOR

Model Number	500118200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return, although images were provided and the investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
A customer reported "the barb could not be pushed back completely.The needle had to be removed from the patient using a scalpel.This inevitably resulted in tissue damage to the patient.Only one needle from the package was affected.The product was disposed of." photos were provided.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.No samples were returned by the customer for evaluation.Additionally, the photographic evidence provided by the customer appeared to support the reported allegation.The inability to retract the barb may have resulted from several potential factors, including tissue entrapment or mechanical resistance.However, without receiving the sample, we are unable to perform a comprehensive investigation to determine the root cause.As a result, we cannot determine a definitive root cause or establish an appropriate corrective action at this time.Additional information provided in h.3., h.6.And h.11.

• Brand Name: PROSTATE STABILIZATION SET 18GA X 20CM
• Common Device Name: SYSTEM, APPLICATOR
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23677430
• Report Number: 0001625425-2025-01148
• Device Sequence Number: 21407078
• Product Code: IWJ
• UDI-Device Identifier: 00886333004393
• UDI-Public: (01)00886333004393(17)3006259(10)11627654
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 500118200
• Device Lot Number: 11627654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown