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

Catalog Number	0012
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a mastectomy, they were using harmonic focus and megadyne 0012 at the same time.They saw a flash of flame.The patient had large amounts of "greasy fat" because she was morbidly obese and while dissecting the tissue, the team noticed particles 'spraying' more than normal.The surgeon did instruct the resident to use the bovie while she used the harmonic scalpel because she wanted to move the case along and did not know of any issue using these device simultaneously.The team did notice a brief 'flash fire ball' above the patient and the devices.The patient's tissue didn't appear to be affected at all by the brief occurrence because it was above the field and the team thoroughly inspected the tissue.No injury noted.The team removed the equipment from use.New units and devices were obtained for case completion.
Additional Manufacturer Narrative
(b)(4).The surgeon and staff stated it was a flash of flame about the size of a fist.They mentioned that they were using the focus and the 0012 simultaneously to progress the procedure faster.The flash was above the patient approx.1-2 feet.
Additional Manufacturer Narrative
(b)(4).Investigation summary: 1 each 0012 unknown lot number was received for evaluation.No abnormalities were observed during visual inspection.No damage or insulation damage was observed.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: E-Z CLEAN BLADE 2.5IN
• Common Device Name: E-Z CLEAN BLADE 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8445897
• Report Number: 1721194-2019-00089
• Device Sequence Number: 2887635
• Product Code: GEI
• UDI-Device Identifier: 10614559100080
• UDI-Public: 10614559100080
• 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,Followup,Followup
• Report Date (Section B): 03/13/2019

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: 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 03/13/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/03/2019; 04/18/2019
• Patient Sequence Number: 1