MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ULTRAVAC; APPARATUS, EXHAUST, SURGICAL

Model Number	2110-10EC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After incision was made, bovie was attempted to use and did not activate on field.No fault alarms alerted.Grounding pad was checked and was in the green.Hand piece and grounding pad were disconnected and reconnected.No error messages, but still would not activate.A new hand piece was opened, no change.A new bovie pad was placed on the patient; no change.A new machine was brought in the room and bio med was called.Hand piece still did not work.Bio med checked the machine with a test hand piece which did work correctly.Bio-med suggested a new hand piece from a different lot number.A new lot number was opened and worked without issue on both machines (covidien valley lab consoles cn50920/cn50754).Bovie site was clear of an injury.No harm to patient was evident but did cause a delay intra-operatively.

• Brand Name: ULTRAVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st; draper UT 84020
• MDR Report Key: 10100787
• Report Number: 10100787
• Device Sequence Number: 2680238
• Product Code: FYD
• UDI-Device Identifier: 10614559104743
• UDI-Public: (01)10614559104743
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/30/2020
• Report Date (Section F): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2110-10EC
• Device Lot Number: 7913
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/30/2020