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	08/01/2019
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 a mass excision there was a flash as the surgical site from either the pencil or the tip.It is unknown how they finished the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/4/2019.Additional information obtained: no burn occurred, but there was a flash arc.Investigation summary: retained samples: the retained samples of both lot numbers have been inspected visually and tested electrically.The electrical impedance measurement was performed.All samples were found to perform within limits.No faults could be detected.Customer samples: no samples were made available for further investigation to the date of this report.Conclusion: the tested retained samples performed well within specified limits.Production and test records were reviewed for the lot numbers:181025-2404 and 190308-2402 and no faults could be detected.All conducted tests for the claimed lots showed no deviation.The initial adhesion test after the production was reviewed and no deviations could be detected for both lot numbers.All tests were passed successfully and all measurements were within acceptable limits.

• 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: 8946945
• Report Number: 1721194-2019-00116
• Device Sequence Number: 2575999
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 0012AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1