MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Catalog Number	0013M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary 1 each 0013m lot number 187021 was received for evaluation.During visual inspection found excessive charred eschar and melted on the very tip of the device.Excessive charred eschar was found at the distal edge of the black insulation.Blood and eschar were found on the entire length of the blue insulation.The most likely cause of this damage is the result of eschar tissue build up on the electrode.It is a known fact 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 "explosion" could occur.It was evident during the evaluation that ptfe coating was missing and the charring on the device, indicating that the tip had most likely been used for a long duration which would indicate the tip was extremely hot at the time of the event.It's suggested (and standard practice) that users can minimize the risk of flame/flash "explosion" to the tips by avoiding using damaged tips (insulation), excessive heat to the tip, use of a damp sponge to remove eschar build up on the tip and oxygen enriched environments.The complaint is confirmed as use related.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a thyroidectomy the electrode tip caught on fire and was burning like a match.It is unknown how the case was completed.There were no adverse patient consequences.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9276105
• Report Number: 1721194-2019-00135
• Device Sequence Number: 11364760
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• 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
• Report Date (Section B): 10/09/2019

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: No Information
• Device Catalogue Number: 0013M
• Device Lot Number: 187021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1