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

Model Number T200-020

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 319938902
• Report Number: 3010760216-2023-00002
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00857356008064
• UDI-Public: (01)00857356008064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162475NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1