MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 6.5IN; E-Z CLEAN BLADE MODIFIED 6.5 INCH

Model Number	0014M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during surgery, the electrode 0014m together with medtronics force triverse (ft3000) started to spark and created a small flame.No fluid or anything else caught fire.It was reported there were no patient consequences.It's unknown whether the procedure was delayed or completed successfully, or if fragments were generated and easily removed without additional intervention.It's unknown whether other medical intervention was required.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/21/2020.Investigation summary: ten each of 0014m lot number 193351 were received for evaluation.The devices were new in sealed pouches.The actual device used during the event was not returned.The devices were found to be within specifications.The complaint is unconfirmed.

• Brand Name: E-Z CLEAN BLADE MOD 6.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 6.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9476434
• Report Number: 1721194-2019-00142
• Device Sequence Number: 2927993
• Product Code: GEI
• UDI-Device Identifier: 10614559100172
• UDI-Public: 10614559100172
• 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): 11/22/2019

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 Model Number: 0014M
• Device Catalogue Number: 0014M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1