MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY

Model Number 89-10552

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem Crushing Injury (1797)

Event Date 11/27/2021

Event Type  malfunction  

Event Description

Cautery device gave error message upon being plugged in, cautery working intermittently surgeon continued to use; another was not requested at that time as it was doing the task.When set down for a moment and not in holster, it turned on with no input and burned a hole in the patients skin.The device was immediately replaced at this point.The patients skin was sutured and dressed with the rest of the incision.Biomed tested bovie pencil with a different esu.Cut intermittently functioning.Coag functional.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13470754
• MDR Text Key: 285161795
• Report Number: 13470754
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Device Model Number: 89-10552
• Device Catalogue Number: 89-10552
• Device Lot Number: 55474115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA
• Patient Sex: Male