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).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
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, tear or weakness in the insulation was noted and the device was replaced.There was a 3-5 min delay, no patient complications known.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/7/2018.Investigation summary: one 0100s device was received.There was also packaging for lot number 180822.Uncertain if this device was from that lot number.The device had split insulation.The device shows extreme evidence of rigid device contact with the distal end of the device.Evidenced by the insulation being shaved, peeled and split.Insulation damage is possibly from cannula contact during device removal.Multiple breeches in insulation all go from proximal toward distal in direction of damage which indicates damage occurring when device is being withdrawn.No signs of arcing.User damage unable to determine if the device had arced.A dhr review was performed, and there is no evidence of device defect or malfunctions.

• 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: 7627571
• Report Number: 1721194-2018-00021
• Device Sequence Number: 11311434
• 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,Followup
• Report Date (Section B): 06/07/2018

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: 02/28/2023
• Device Catalogue Number: 0100S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1