MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; EZ CLEAN ELECTRODE

Model Number	0118A
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End user reported that there was current "leaking" through the insulation.We evaluated the returned sample.There were clear indications that the device had been misused.There was evidence that the electrode had not been fully inserted into the handpiece which is cautioned against in the product ifu.This is seen by residue from and alternate current route.Also, there are marks in the insulation from the use of some type of clamping instrument which damaged the insulation showed signs of residue meaning the damge was done before the device was used.This is cautioned against in our ifu.The insulation was also compressed on the device.We conclude that the device was used beyond the scope of the design of the product and contrary to the ifu for the product.This report was initially received as a problem with the insulation.We did not become aware of the patient injury until 12/02/2016.
Event or Problem Description
Per customer: the surgeon noticed that tissue next to the insulated part of the surgical tip was being affected by the diathermy, immediately upon operating.Tissue next to the insulated portion of the megafine tip was damaged dur to what appeared to be current "leaking" through the insulation.The surgeon was required to make an additional suture, leaving the patient with an additional scar.

• Brand Name: MEGADYNE
• Common Device Name: EZ CLEAN ELECTRODE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84120
• MDR Report Key: 6223238
• Report Number: 1721194-2017-00001
• Device Sequence Number: 509648
• Product Code: JOS
• UDI-Device Identifier: 10614559101414
• UDI-Public: 10614559101414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: D009817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Model Number: 0118A
• Device Catalogue Number: 0118A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR