• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEROYAL
Type of Device
GENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
200 debusk lane
powell TN 37849
MDR Report Key13470754
MDR Text Key285161795
Report Number13470754
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Number of Events Reported1
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 Number89-10552
Device Catalogue Number89-10552
Device Lot Number55474115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/15/2021
Event Location Hospital
Date Report to Manufacturer02/07/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age20805 DA
Patient SexMale
-
-