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

Catalog Number	0100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy the insulation detached from the distal end of the tip around the wire electrode.A second like device was used to complete the procedure with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/18/2018.Investigation summary: received one each of the 0100, lot number 181795.The insulation was detached.The l hook was covered in black eschar.The distal end of the insulation was completely torn away approximately 5/8 of an inch from where it should end, there was a split line that the tear follows.There are impression marks most likely from a rigid object or instrument/device.There was shaving or slicing, hard to tell due to the degree of disfiguring of the insulation.This could be the result of excessive mechanical loading during use (contact with another rigid object).Power settings don't appear to have been excessive, the insulation was compromised prior to the splitting as evidenced by the impression marks.Use related.A dhr review was performed, and there is no evidence of device defect or malfunctions.

• Brand Name: E-Z CLEAN L-WIRE LAP 33CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7777067
• Report Number: 1721194-2018-00030
• Device Sequence Number: 2217737
• Product Code: GEI
• UDI-Device Identifier: 10614559100677
• UDI-Public: 10614559100677
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K913281
• 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
• Report Date (Section B): 07/27/2018

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/18/2018
• Patient Sequence Number: 1