MAUDE Adverse Event Report: Riverpoint Medical LLC Brachytherapy Needle; 18G x 20cm Pre-Waxed Brachytherapy Needle with Two (2) COUPLES 0.8MM X 5MM Gold

Model Number	GM0851-SS20-1820
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury

• Brand Name: Brachytherapy Needle
• Common Device Name: 18G x 20cm Pre-Waxed Brachytherapy Needle with Two (2) COUPLES 0.8MM X 5MM Gold
• Manufacturer (Section D): Riverpoint Medical LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): Riverpoint Medical LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 50226803
• Report Number: 3009681798-2026-00034
• Device Sequence Number: 10364807
• Product Code: KXK
• UDI-Device Identifier: 00812444024234
• UDI-Public: 00812444024234
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: D125929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Device Model Number: GM0851-SS20-1820
• Device Lot Number: 25061920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown