MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE ULTRAVAC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 211010EC

Device Problem Defective Component (2292)

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

Event Date 05/28/2020

Event Type  malfunction  

Event Description

Device would not work when plugged in.Fda safety report id # (b)(4).

• Brand Name: MEGADYNE ULTRAVAC
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; draper UT 84020
• MDR Report Key: 10118396
• MDR Text Key: 194116548
• Report Number: MW5094821
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• 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

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211010EC
• Device Lot Number: 7911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 54