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	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: one 0013m electrode was returned for evaluation.The entire electrode tip down approximately ¼ of the insulation was found with excessive black charred eschar buildup, 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 most likely cause of the report is the electrode was not property cleaned to remove excessive eschar buildup and in the right conditions can ignite the eschar.A manufacturing record evaluation was performed for the finished device lot numbers, and no non-conformances were identified.
Event or Problem Description
It was reported that during a tonsillectomy and adenoidectomy, while the product was in use outside the patient the tip sparked and flamed.Case completed with another device of the same product code.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: 8679000
• Report Number: 1721194-2019-00099
• Device Sequence Number: 2349113
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 05/13/2019

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: 05/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1