MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN MEGAFINE NEEDLE 2IN; E-Z CLEAN MEGAFINE NEEDLE 2 INCH

Catalog Number	0118
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/12/2018.Investigation summary: one each electrode was returned for evaluation.During inspection under magnification the black most distal insulation on the needle is peeled back, melted and rolled.The metal needle is melted.Much of the ptfe coating is missing on the distal end of the needle indicating that the needle may have been used for a long period of time.The electrode tip and insulation is charred.The electrode has no flammable material built into the product therefore it is unlikely that the flame/flash/fire occurred as a result of the electrode tip materials.Most likely cause of the report was a result of tissue build up on the electrode.The product ifu states that tissue buildup needs to be removed to decrease flame/flash/fire.The tip becomes hot upon activation and if tissue build up were to exist it results in increase temperature which could cause flame/flash/fire.It was evident during the evaluation that ptfe coating was missing from the distal tip of the needle, 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.The outcome of the evaluation determined the cause of the reported complaint to be user related.The batch history record was reviewed and no defects, nc¿s or deviations related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an anterior cervical diskectomy, collaged tip looked like a birthday candle.It looked like the tip had melted a bit, there was a lot of tissue on it, and that is what caused the little flame.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: E-Z CLEAN MEGAFINE NEEDLE 2IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7871686
• Report Number: 1721194-2018-00035
• Device Sequence Number: 16621556
• Product Code: GEI
• UDI-Device Identifier: 10614559101278
• UDI-Public: 10614559101278
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 0118
• Device Lot Number: 176376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/12/2018
• Patient Sequence Number: 1