MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 4.0IN; E-Z CLEAN BLADE MODIFIED 4.0 INCH

Catalog Number	0014AM
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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 open procedure, the tip of the 0014am took fire.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/19/2019.Investigation summary: 1 each 0014am was returned for evaluation.Customer description; flame/flash/fire.Charred eschar residue is visible at the electrode tip and down the insulation of the electrode.A buildup of tissue debris/eschar appears to have collected under the insulation where the tip meets the insulation also.The most likely cause of the report is this tissue/ debris/eschar build up ignited during use.The product ifu instructs the user to clean off debris from the electrode with a soft sponge to prevent buildup.The complaint is confirmed as use related.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: E-Z CLEAN BLADE MOD 4.0IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 4.0 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8475679
• Report Number: 1721194-2019-00091
• Device Sequence Number: 14142876
• Product Code: GEI
• UDI-Device Identifier: 10614559100165
• UDI-Public: 10614559100165
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 0014AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1