MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PLASMABLADE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PS210-030S

Device Problems Failure to Cut (2587); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/08/2020

Event Type  malfunction  

Event Description

The plasmablade was not cutting or coagulating.Another blade had to be opened to complete the case.

• Brand Name: PLASMABLADE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 11093607
• MDR Text Key: 224312460
• Report Number: 11093607
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/07/2020,11/23/2020

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 Catalogue Number: PS210-030S
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1