MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN MEGAFINE NDLE 2.5IN; E-Z CLEAN MEGAFINE NEEDLE 2.5 INCH

Catalog Number	0118A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Maude report # mw5089782.Investigation summary: 7 each 0118a lot 193480 was returned for evaluation.6 unopened devices and 1 each used.No manufacturing defects were found during inspection of the 6 unused devices.The used device: the black most distal insulation on the needle is peeled back and has a melted appearance.Also, the tip of the mental needle tip is melted.Charring eschar residue is visible at the base of the damaged insulation.The most likely cause of this damage to the insulation is due to excessive mechanical load/forces to the insulation.A buildup of tissue debris or eschar appears to have collected under the insulation with evidence of this tissue debris visible at the base of the split insulation.All the ptfe coating is missing on the distal end of the needle and the metal tip is melted.This damage is most likely caused by operating the electrosurgery equipment (generator) at high power settings with continual activation of the electrode for long periods or by placing the electrode tip against another instrument causing extreme heat which results in melting of the tip.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 brow lift, the doctor was using the megadyne e-z tip with a megadyne megapower generator for thirty minutes then the tip turned into a glowing ball and the insulation bubbled up on it, while activating.A second like e-z tip from a different lot was used to complete the procedure.There were no patient consequences reported.

• Brand Name: E-Z CLEAN MEGAFINE NDLE 2.5IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9281824
• Report Number: 1721194-2019-00134
• Device Sequence Number: 3603997
• Product Code: GEI
• UDI-Device Identifier: 10614559101414
• UDI-Public: 10614559101414
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 0118A
• Device Lot Number: 193480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1