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

Catalog Number PS210-030S

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

Event Type  malfunction  

Event Description

Plasma blade gave an error message and would not work.

• 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: 11100350
• MDR Text Key: 224527424
• Report Number: 11100350
• 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

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PS210-030S
• Was Device Available for Evaluation?: Yes
• 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: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1