MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN L-WIRE LAP 45CM; E-Z CLEAN WIRE L-WIRE LAP 45CM

Model Number	0100L
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/6/2020.Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.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 laparatomy vaginal hysterectomy, the teflon coating around the electrode exploded.A second like device was tried and it did the same thing.A force triad generator was being used at that time.It is unknown how the procedure was completed and there were no patient consequences reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/13/2020.Additional information: two photos were provided.A slit in the insulation was observed with excessive charred eschar extending from the tip to the bottom of the slit damage.It was also evident from the photos that the coating was completely missing indicating the tip has been used for long durations with excessive heat and continued to be used after the insulation was split and damaged.It is known that the tip becomes hot upon activation and if eschar tissue buildup is present it could become a glowing ember and review of the photos of the device indicates the tip was very hot at the time of the event.The complaint is confirmed as user damage.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Additional Manufacturer Narrative
(b)(4).Investigation summary: 1 each 0100l lot 192290 was return.A slit in the insulation was observed with excessive charred eschar extending the from the tip to the bottom of the slit damage.The coating was completely missing indicating the tip has been used for long duration with excessive heat and continued to be used after the insulation was split and damaged.It is known that the tip becomes hot upon activation and if eschar tissue buildup is present it could become a glowing ember and review of the photos of the device indicates the tip was very hot at the time of the event.The complaint is confirmed as user damage.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.,the lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

• Brand Name: E-Z CLEAN L-WIRE LAP 45CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP 45CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9676659
• Report Number: 1721194-2020-00019
• Device Sequence Number: 2704529
• Product Code: GEI
• UDI-Device Identifier: 10614559102640
• UDI-Public: 10614559102640
• Combination Product (Y/N): N
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2020

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 Model Number: 0100L
• Device Catalogue Number: 0100L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020; 01/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/13/2020; 05/14/2020
• Patient Sequence Number: 1