MAUDE Adverse Event Report: COVIDIEN CARDIOVASCULAR PACK; General surgery tray

Model Number	89-4712
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "bovie would not work." the device was requested for return, but it was not received.A supplier notification letter (snl) was issued to the supplier of the bovie.No inventory was able to be inspected as the lafollette branch plant has closed and no inventory is available or being made.Root cause: because this manufacturing facility has closed and no issues have been identified within the review, the root cause cannot be determined.Corrective and preventive actions: because no root cause was able to be determined, no corrective or preventive actions have been taken.Deroyal will continue to monitor for issues around this item and issue.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.
Event or Problem Description
A user facility reported, "bovie would not work.".

• Brand Name: CARDIOVASCULAR PACK
• Common Device Name: General surgery tray
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 25003047
• Report Number: 3005011024-2026-00001
• Device Sequence Number: 9813480
• Product Code: LRO
• UDI-Device Identifier: 00749756604925
• UDI-Public: 00749756604925
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: 89-4712
• Device Lot Number: 62815977
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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