MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLN L-WR LAP SPLIT STEM 33CM; E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM

Catalog Number	0100S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Investigation summary: one 0100s device was received.There was also packaging for lot number 180822.It is uncertain if this device was from that lot number.The device had split insulation.The device had blackened layer of eschar on the outside of the coating which may have been related to arcing, 2-3 mm split in the insulation.There is an impression mark at the leading edge of the split.Unable to determine the initial cause.Splitting doesn't look excessive but is usually caused by a combination of higher power activation and mechanical loading (physical pressure to insulation) of the insulation.Unable to determine cause with any certainty.It is likely use related.A dhr review was performed, and there is no evidence of device defect or malfunctions.
Event or Problem Description
It was reported that during a gyn procedure, a large flash or arcing was noted during activation within the abdominal cavity.Upon inspection, a tear or weakness in the insulation was noted and the device was replaced.There was a 3-5 min delay, no patient complications known.

• Brand Name: E-Z CLN L-WR LAP SPLIT STEM 33CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7856650
• Report Number: 1721194-2018-00034
• Device Sequence Number: 13944085
• Product Code: GEI
• UDI-Device Identifier: 10614559100677
• UDI-Public: 10614559100677
• Combination Product (Y/N): N
• PMA/510(K) Number: K913281
• 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): 06/06/2018

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 Catalogue Number: 0100S
• Device Lot Number: 180822.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1