MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC EXTREMITY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10552
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received reporting the cautery pencil in the (cmc extremity pack) burned the patient.Additional information was received from the user facility stating, "the cautery device gave an error message upon being plugged in.The cautery was working intermittently, so the surgeon continued to use it.Another was not requested at that time, as it was doing the task.When it was set down for a moment and not in the holster, it turned on with no input and burned the patient's skin.It caused two areas of skin damage, limited to two small 1 cm burns on the patient's leg.The device was immediately replaced at this point.The patient's skin was sutured and dressed with the rest of the incision.The burns are expected to heal uneventfully.The patient was notified after the case.Biomed tested the bovie pencil with a different esu.Cut intermittently functioning.Coag functional." deroyal received initial information indicating that pencil was not placed into holster during surgical procedure.The cautery pencil has not been returned to deroyal for evaluation.(b)(4).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 in the (cmc extremity pack) reported to have burned the patient.
Additional Manufacturer Narrative
Root cause: no root cause was identified.The cautery pencil has not been returned to deroyal for evaluation.Corrective action: a corrective action has not been taken due to the root cause determination.Production records were reviewed, and no issues were found.An inventory check was made, a total 8 cases of the cautery pencils were inspected, and no functional 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: CMC EXTREMITY 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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 13088239
• Report Number: 3005011024-2021-00015
• Device Sequence Number: 5433329
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• 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): 01/18/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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