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

Model Number	0100S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/3/2020.Batch #unk.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, the insulation became detached from the tip.It is unknown how the case was completed.No patient consequences were reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Investigation summary: one each 0100 lot 195858 was received for evaluation.During visual inspection a cut in the insulation at the distal end was found, exposing the metal substrate.The most likely cause of this damage is a result of the application of excessive mechanical forces such as contact with other instruments or objects that damage the edge of the insulation.For instance, contact with a sharp edge on the trocar during insertion or removal may cut or slice the insulation.Subsequent use contributes to the continued ¿splitting¿.The complaint is confirmed as user damage.The lot number provided is for part id 0100.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: E-Z CLEAN L-WIRE LAP 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: 9661977
• Report Number: 1721194-2020-00015
• Device Sequence Number: 2778372
• Product Code: GEI
• UDI-Device Identifier: 10614559100677
• UDI-Public: 10614559100677
• Combination Product (Y/N): N
• 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): 01/06/2020

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 Expiration Date: 01/31/2017
• Device Model Number: 0100S
• Device Catalogue Number: 0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1