MAUDE Adverse Event Report: US MEDICAL INNOVATIONS CANADY HYBRID PLASMA SCALPEL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Detachment of Device or Device Component (2907); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

Two canady handpieces (same lot) did not allow argon gas to flow through.Tank was checked and was full.Switched to a different handpiece (85 mm paddle) and it worked as it should.On the same day, two other handpieces had issue with tip not staying attached.We have had this problem repeatedly over last 6-8 weeks.

• Brand Name: CANADY HYBRID PLASMA SCALPEL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): US MEDICAL INNOVATIONS; 6930 carroll ave, 2nd flr; ste 200; takoma park MD 20812
• MDR Report Key: 14358865
• MDR Text Key: 291496913
• Report Number: MW5109627
• Device Sequence Number: 4
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1