MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE 2.5IN; E-Z CLEAN BLADE 2.5 INCH

Catalog Number	0012
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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 an unknown procedure, the cautery pencil, caught fire at the tip of the handpiece.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/28/2019.Investigation summary: 1 each 0012 lot 183800 was returned for evaluation.The pencil was not returned.During visual inspection charring debris on the blade and the entire length of the blue insulation.Also found charring debris on the edge of the blue insulation where it meets the shaft.The most likely cause is that the pencil/electrode was exposed to excessive fluids/tissue that were able to be pushed inside of the pencil by evidence found on the electrode that the fluids/tissue was found on the section of the electrode that would have been encased inside the pencil¿s nose.The nose cone has been developed for this type of occurrence, which would prevent fluids passing from the nose of the pencil into the internal pencil.The instruction for use instructs the user to clean the electrode to prevent buildup.The complaint is confirmed as use related.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: E-Z CLEAN BLADE 2.5IN
• Common Device Name: E-Z CLEAN BLADE 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8678673
• Report Number: 1721194-2019-00096
• Device Sequence Number: 3029746
• Product Code: GEI
• UDI-Device Identifier: 10614559100080
• UDI-Public: 10614559100080
• Combination Product (Y/N): N
• PMA/510(K) Number: K862221
• 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): 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 Expiration Date: 06/30/2023
• Device Catalogue Number: 0012
• Device Lot Number: 183800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/22/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1