MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER

Model Number	0035H
Medical Device Problem Codes	Fire (1245); Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a nephrectomy, the electrode caught on fire while dissecting through tissue.The generator was a megapower 1000 set on cut: 35 pure, coag: 35, coag 1.They had just cut through a muscle layer and were above the tissue when the tip produced a flame.Surgery was not delayed due to the reported event.They opened a new pencil and the procedure was completed successfully.No fragments were generated and there were no patient complications reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/21/2020.Investigation summary: the device was received with burn marks at the coating and with the insulation with no apparent damage.The instrument was tested for continuity and was found to be conforming.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to what caused this issue.

• Brand Name: E-Z CLEAN PNCL BTN HLSTR
• Common Device Name: E-Z CLEAN PENCIL BUTTON HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 10248427
• Report Number: 1721194-2020-00036
• Device Sequence Number: 16277715
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (Y/N): N
• PMA/510(K) Number: K965054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 0035H
• Device Catalogue Number: 0035H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/21/2020
• Patient Sequence Number: 1