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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.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 procedure, a blue protector/insulation piece on the megadyne bovie tip dislodged from the bovie during routine cleaning of the tip.The piece was caught by or staff before it fell into and was lost in the cavity of the patient.It is unknown how the case was completed.There were no patient consequences.No additional information is available at this time.

• 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: 9911217
• Report Number: 1721194-2020-00029
• Device Sequence Number: 16961918
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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
• Device Lot Number: 193733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1