MAUDE Adverse Event Report: TRICE MEDICAL, INC. SEG-WAY ECTR-D; ECTR-D KIT OF DISPOSABLE SURGICAL INSTRUMENTS

Model Number	T400-023
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user reported that there was a red deposit on the side of a pair of scissors inside the disposable kit of instruments.
Additional Manufacturer Narrative
The device has been returned to us, but the investigation has not yet been completed.A follow-up report shall be filed when new information is available.There was no patient involvement or impact on the user.
Additional Manufacturer Narrative
The device was returned and evaluated.A red deposit was present on the side of the scissors.It was adhered to the metal surface.It appeared epoxy-like with a slightly clumping or bead-like contour.It did not readily detach from the metal.Samples were sent for outside laboratory testing.Testing confirmed that there was no hemoglobin in the material, and thus it was not a deposit of blood on the part.Testing was inconclusive in identifying the exact substance.It was concluded that the contaminant was deposited on the part during its manufacturing processes.We collaborated with the vendor for the instruments and the packaging contract manufacturer to prevent a recurrence of the issue.We subsequently discontinued distributing the instrument our ectrd kits.We apologize for the delay in reporting the follow-up results for this incident report.External laboratory test results and investigations took an extended period of time.And the filing was inadvertently delayed.

• Brand Name: SEG-WAY ECTR-D
• Common Device Name: ECTR-D KIT OF DISPOSABLE SURGICAL INSTRUMENTS
• 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 warren blvd; suite 100; malvern, PA 19355 ; 9492388220
• MDR Report Key: 16519210
• Report Number: 3010760216-2023-00001
• Device Sequence Number: 3353661
• Product Code: KDD
• UDI-Device Identifier: 00857356008156
• UDI-Public: (01)00857356008156(17)241031(10)2210039701
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: NA#S-P#NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2025

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: 10/31/2024
• Device Model Number: T400-023
• Device Catalogue Number: T400-023
• Device Lot Number: 2210039701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Unknown