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

Model Number	0012M
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 2/22/2020.Additional information: the treatment was excision of the burned skin edge at the time of surgery.The remaining burns healed well with simple dressings.No long term effects anticipated.Investigation summary: one each 0012m unknown lot number was received for evaluation.During visual inspection found a ¿burn hole¿ in the mid-section of the electrode shaft.Evaluation under magnification revealed that in addition to the thermal damage caused by the current exiting the electrode at that point, there are also markings on the insulation consistent with mechanical damage typically caused by grasping the electrode with a clamping device.The most likely cause of this type of damage is related to the application of excessive forces such as contact with other instruments or objects that damage the insulation.The complaint is confirmed as user damage.
Event or Problem Description
It was reported that during a breast procedure, the tip was megadyne 0012m, the pencil was covidien and the diathermy machine was martin.The diathermy set at 40/40 pure cut/spray.Surgeon was working deep in the breast when he noticed 2 or 3 burn marks on the outer breast tissue at least a few cms away from surgical site.No obvious moment when it happened, no spark/jump seen, unknown how long it took them to notice as hands were helping to hold the breast.They are also unsure of if it happened whilst using cut or coag.When they looked closer at the tip it appeared to also have a burn type mark where it was connecting into the pencil.Patient consequence not reported.

• 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: 9742653
• Report Number: 1721194-2020-00023
• Device Sequence Number: 1815364
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0012M
• Device Catalogue Number: 0012M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention