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

Catalog Number	0012AM
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/28/2018.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during an open right femoral artery thrombendarterectomy, when the device was used to the groin, the coating portion started melting and it made a fire.Output level of the electrical scalpel was 40 and the surgeon disinfected the device with isodine.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Investigation summary: received one each 12am, with lot number unknown.The electrode appears to be intact.The distal tip of the stainless steel electrode is melted on one corner of the blade.The ptfe coating has been damaged due to excessive heat and likely due to high power settings as most of the ptfe is vaporized.The insulation jacket also has a heat signature showing high temperature usage.There is no indication of anything that would cause a fire.There is also no evidence of mechanical contact or damage.The coating, substrate and insulation jacket are all damaged due to high temperature use.None of these components are individually or collectively flammable.The flame reported is not from product but likely from fatty tissue or fluid burn off.Confirmed as user damage.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: E-Z CLEAN BLADE MOD 2.75IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7824854
• Report Number: 1721194-2018-00033
• Device Sequence Number: 1808694
• Product Code: GEI
• UDI-Device Identifier: 10614559100080
• UDI-Public: 10614559100080
• 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): 08/09/2018

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 Catalogue Number: 0012AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 12/07/2018
• Patient Sequence Number: 1