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	04/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Error displayed once plugged into electrical surgical unit machine "check instrument, mono 2 handswitch pressed, release switch, if issue persists, replace instrument" and handpiece non-operational.Another handpiece was used on secondary esu in room for case.This functioning handpiece was then tested on the first esu machine at end of case to confirm that it was a singular handpiece issue and worked as expected.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 5/7/2023 reporting error displayed once plugged into electrical surgical unit machine "check instrument, mono 2 handswitch pressed, release switch, if issue persists, replace instrument" and handpiece non-operational.Another handpiece was used on secondary esu in room for case.This functioning handpiece was then tested on the first esu machine at end of case to confirm that it was a singular handpiece issue and worked as expected.The sample has not been returned to deroyal for 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.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 5/7/2023 reporting error displayed once plugged into electrical surgical unit machine "check instrument, mono 2 handswitch pressed, release switch, if issue persists, replace instrument" and handpiece non-operational.Another handpiece was used on secondary esu in room for case.This functioning handpiece was then tested on the first esu machine at end of case to confirm that it was a singular handpiece issue and worked as expected.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: 16929670
• Report Number: 3005011024-2023-00027
• Device Sequence Number: 6805445
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2023
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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