MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. PNCL 12 USE BTN HLSTR 10FT CORD; PENCIL 12 USE BUTTON HOLSTER 10 FT CORD

Catalog Number	3035H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary one each ez pen pencil was returned for evaluation.Visual inspection indicates the pencil is in good condition, no fluids or debris.Functional testing was performed by pressing the cut and coag buttons on the pencil while checking the continuity output with a multimeter.The resistance reading was within specification.Also tested pencil using the lab generator the pencil was plugged into the generator and both the cut and coag switches on the pencil were pressed the check for functionality of the device, both buttons functioned as intended.The reported complaint is unconfirmed.The pencil involved passed all testing.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a tonsillectomy and adenoidectomy, while the product was in use outside the patient the tip sparked and flamed.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: PNCL 12 USE BTN HLSTR 10FT CORD
• Common Device Name: PENCIL 12 USE BUTTON HOLSTER 10 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8678772
• Report Number: 1721194-2019-00098
• Device Sequence Number: 14017548
• Product Code: GEI
• UDI-Device Identifier: 10614559102541
• UDI-Public: 10614559102541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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 Catalogue Number: 3035H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1