MAUDE Adverse Event Report: Trice Medical, Inc. Seg-WAY; Disposable Retrograde Knife

Model Number	200-1006
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury

• Brand Name: Seg-WAY
• Common Device Name: Disposable Retrograde Knife
• Manufacturer (Section D): Trice Medical, Inc.; 40 general warren blvd.; suite 100; malvern PA 19355
• Manufacturer (Section G): Trice Medical, Inc.; 40 general warren blvd.; suite 100; malvern PA 19355
• Manufacturer Contact: david vancelette ; 40 general warrenn blvd.; suite 100; malvern, PA 19355 ; +1(949)238-8220
• MDR Report Key: 50569725
• Report Number: 3010760216-2026-00004
• Device Sequence Number: 10533363
• Product Code: LXH
• UDI-Device Identifier: 00857356008194
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2025
• Device Model Number: 200-1006
• Device Catalogue Number: 200-1006
• Device Lot Number: 0962102
• 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: 06/30/2025
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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