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	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Investigation summary: one each 0013m unknown lot number was returned for evaluation.During visual inspection charred eschar was observed on the needle tip and on the black insulation.Blood/eschar was observed the entire length of the blue insulation.The needle tip appears to be melted with a ball of charred eschar at the tip.All 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 most likely cause of the reported complaint was a 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/fire could occur.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 complaint is confirmed as use related.The lot was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a thyroidectomy, the needle tip sparked and caught on fire.A second like tip was used to complete the procedure.There were no patient consequences reported.

• 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: 9298512
• Report Number: 1721194-2019-00136
• Device Sequence Number: 2426898
• 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): 10/16/2019

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 Catalogue Number: 0013M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/08/2019
• Patient Sequence Number: 1