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

Model Number 2110-10EC

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Bovie pencil was plugged in correctly.Trouble shooting took place to eliminate other possible issues.Bovie pad was checked and was intact and ok, bovie machine was checked by biomed and was not in error, bovie pencil was replaced and it worked.

• Brand Name: ULTRAVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st; draper UT 84020
• MDR Report Key: 10133557
• MDR Text Key: 194513394
• Report Number: 10133557
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 2110-10EC
• Device Lot Number: 7607
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1