MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Catalog Number	0012M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2018, a few minutes after the case started, the surgeon began using cautery.The surgeon, pa, and tech all saw a 2 inch tall flame for a brief second and then it was gone.The flame was immediately reported to the operating room nurse.The bovie tip that caused the flame did not cause damage to the patient, but it was removed from the field and a new bovie tip was used for the remainder of the case.The bovie tip that caused the flame was a 0012m megadyne tip.
Additional Manufacturer Narrative
(b)(4).A dhr review was performed, and there is no evidence of device defect or malfunctions.(b)(4).
Additional Manufacturer Narrative
(b)(4).Date sent: 3/13/2019.
Additional Manufacturer Narrative
(b)(4).Investigation summary: one each 0012m lot number 183744 was returned for evaluation.During visual inspection the tip was found melted and with black charring and excess eschar buildup on the tip.The tip was likely used at high power setting and likely long activations which would indicate the tip was extremely hot at the time of the event.Also observed the black modified insulation was melted and rolled onto itself.The likely cause of the flame is the result of eschar tissue buildup and the device being used at high setting and long activations.The product¿s ifu instructions the user to use a damp gauge or sponge to reduce eschar buildup.Also instructs the user to use the lowest possible power settings to achieve the desired effect.The complaint is confirmed as user damage.A dhr review was performed, and there is no evidence of device defect or malfunctions.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8125625
• Report Number: 1721194-2018-00058
• Device Sequence Number: 16452378
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/12/2018

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: 06/30/2023
• Device Catalogue Number: 0012M
• Device Lot Number: 183744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 12/12/2018; 03/22/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/08/2019; 03/13/2019; 04/03/2019
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 74