MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Catalog Number	0013M
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).
Event or Problem Description
It was reported that during an unknown surgery the surgeon was using a covidien ft10 electrosurgical generator unit (esu) serial # (b) (4) and a megadyne bovie needle tip-lot #183471 and encountered a spark and a small flame in the operating room.Staff removed the tip and replaced it with a regular megadyne bovie tip- lot# 180191 and again encountered sparks and a small flame.Staff removed the esu unit and no additional sparks or flame occurred.The initial unit was set at thirty cut and thirty coag when the spark occurred.Then, the unit was turned down to twenty cut and twenty coag with the same result.It is unknown if another like device was used to complete the procedure.There were no patient consequences.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7877539
• Report Number: 1721194-2018-00037
• Device Sequence Number: 1939835
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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: 05/31/2023
• Device Catalogue Number: 0013M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Patient Sequence Number: 1