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

Model Number 2110-10EC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/11/2020

Event Type  malfunction  

Event Description

Rn alerted by surgeon that bovie was not working.Rn unplugged/re-plugged, would work for a moment then not work.Rn tried another esu with same problem.Bovie replaced and functioned appropriately.

• 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: 9980966
• MDR Text Key: 188342904
• Report Number: 9980966
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110-10EC
• Device Catalogue Number: 211010EC
• Device Lot Number: 7827
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 390 DA