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

Model Number	0035H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.A device history record review could not be performed because a lot number was not provided by the customer.With limited information provided, we may only continue to track and trend for the defective condition.
Event or Problem Description
It was reported by the rep during an exploratory laparotomy with the setting on 40.40 during the opening of the midline incision, the device was arching and flames were shooting out of the tip.A second device was tried, and it did the same thing.The patient had no implants or tattoos.The procedure was completed with a third like device with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: one each 0035h unknown lot number was returned for evaluation.During visual inspection, charred eschar was found on the electrode tip.The most likely cause of the reported event is a result of eschar tissue build up on the electrode.It is a known that the tip becomes hot upon activation and if eschar tissue build-up were to exist it could become a glowing ember and with the right conditions such as an oxygen enriched environment or alcohol prep solutions, a burst of flames/flash could occur.It was evident during the evaluation that ptfe coating was mostly missing from the distal tip of the electrode, indicating that the tip was extremely hot at the time of the event.It is recommended to use of a damp sponge to remove eschar build up on the tip.The complaint is confirmed as use error.

• 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: 9589040
• Report Number: 1721194-2020-00012
• Device Sequence Number: 11391230
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/20/2019

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: 0035H
• Device Catalogue Number: 0035H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1