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

Model Number 2110-10EC

Device Problems Intermittent Continuity (1121); Smoking (1585); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Event Description

Smoke-evac bovie "cut" not working from hand switch ref 211010ec, lot 7871, exp 12/23/2024.No patient listed.Megadyne ultra vac failed to work on a case.Ref 211010ec, lot 7898, exp 1/13/2025.Received replacement handpiece and same thing - no functioning buttons.Ref 211010ec, lot 7871, exp 12/23/2024 - replaced with stryker handpiece and machine worked just fine.Two bovies in the operating room malfunctioning: both are ref 211010 ec, ultra vac lot 7898, exp 1/13/2025.Ultra vac blue bovie not working during case - checked all connections and made sure patient was grounded but had to grab a different bovie, same style and one that worked.Ref 21101 oec - no lot number nor expiration available.Blue bovie working only intermittently.No patient harmed.

• 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: 10137544
• MDR Text Key: 194627097
• Report Number: 10137544
• 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: 05/12/2020

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: 7871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 118