MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CARDIAC BRING BACK PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10537
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting cautery pencil failed.Had to open a new one.The sample has been returned and is under evaluation at this time.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Cautery pencil failed.Had to open new one.
Additional Manufacturer Narrative
A complaint was received on 4/21/2023 reporting cautery pencil failed.Had to open a new one.The sample was returned and evaluated.The root cause was determined to be the manufacturing operator was not correctly following the soldering chip procedure.There was a soldering bridge found in the pc board causing the cautery pencil to malfunction.Corrective action: all manufacturing operators involved were retrained on the soldering chip procedure.Production records were reviewed, and no issues were found.An inventory check of the cautery pencils was made by deroyal, a total of 31 cases of the 88-000002 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CARDIAC BRING BACK PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 16929569
• Report Number: 3005011024-2023-00026
• Device Sequence Number: 6805441
• Product Code: LRO
• UDI-Device Identifier: 00749756364119
• UDI-Public: 00749756364119
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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
• Device Model Number: 89-10537
• Device Catalogue Number: 89-10537
• Device Lot Number: 58450012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown