MAUDE Adverse Event Report: TRICE MEDICAL, INC. MI-TABLET 2; ENDOSCOPIC VIDEO IMAGING DEVICE

Model Number	T200-020
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All components of the device were tested prior to release.No issues were found.After shipment of the device to the customer, no shipping damage was reported.It is possible that the power cord was somehow damaged after delivery and unpackaging, prior to use by the customer.The device has not been returned yet.A follow-up report shall be filed when new information is available.There was no patient involvement or impact on the user.
Event or Problem Description
A facility reported that upon setting up the device, with the power cord plugged into the wall outlet and into the power supply, the power cord started to get warm and generate smoke.

• Brand Name: MI-TABLET 2
• Common Device Name: ENDOSCOPIC VIDEO IMAGING DEVICE
• 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: 17401845
• Report Number: 3010760216-2023-00002
• Device Sequence Number: 14912369
• Product Code: HRX
• UDI-Device Identifier: 00857356008064
• UDI-Public: (01)00857356008064
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162475NA
• 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
• Report Date (Section B): 07/26/2023

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 Model Number: T200-020
• Device Catalogue Number: T200-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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