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

Model Number	89-6867
Medical Device Problem Codes	Fire (1245); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received indicating that a convenience kit (finished good 89-6867, lot 48638185) contained a cautery device that caught fire while a resident was holding it.In the initial report, a sample was reported to be available for evaluation.As of the date of this report, that sample has not been received.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the finished kit was reviewed, and the affected cautery device was identified as a handcontrol push-button pencil (raw material (b)(4)).This device is supplied to deroyal by covidien.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.A scar has been issued to covidien, and as of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is available, this report will be updated.
Event or Problem Description
The convenience kit contained a cautery device that caught on fire while the resident was holding it.This occurred right after use on a patient.
Additional Manufacturer Narrative
Root cause: the affected pencil is supplied to deroyal by covidien.Therefore, a supplier corrective action request (scar) was issued to covidien as well as one sample for evaluation.According to covidien, the returned product did not identify anything that would have caused or contributed to the reported event.The investigation found no evidence of excessive heating or sparking on the returned pencil.The device was plugged into a generator and activated with satisfactory results.No abnormal sparking occurred.The device passed hipot testing, indicating no electrical leakage.The investigation found the device to function normally and within specifications.Corrective action: in its scar response, covidien stated that, due to the root cause investigation, a corrective action was not taken.Investigation summary: an internal complaint (call (b)(4)) was received indicating that a convenience kit (finished good 89-6867, lot 48638185) contained a cautery device that caught fire while a resident was holding it.A sample was returned january 16, 2019, to deroyal.The tip of the pencil showed burn marks, which confirmed the customer's complaint.This sample was forwarded to the vendor january 28, 2019.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the finished kit was reviewed, and the affected cautery device was identified as a handcontrol push-button pencil (raw material 5-6459).This device is supplied to deroyal by covidien.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.A scar has been issued to covidien and response received march 12, 2019.The response was reviewed and accepted by the deroyal complaint investigator.The investigation is complete at this time.If new and critical information is available, this report will be updated.
Event or Problem Description
The convenience kit contained a cautery device that caught on fire while the resident was holding it.This occurred right after use on a patient.

• Brand Name: MAJOR PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8316752
• Report Number: 3005011024-2019-00002
• Device Sequence Number: 16158808
• Product Code: LRO
• UDI-Device Identifier: 00749756731317
• UDI-Public: 00749756731317
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 89-6867
• Device Lot Number: 48638185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1