MAUDE Adverse Event Report: SMITH NEPHEW, INC. COBLATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number EICA5874-01

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Coblation wand was being utilized intra-orally, during use a burn was noticed in the mouth in an area where the tip was not activated at any point.

• Brand Name: COBLATION
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 16077291
• MDR Text Key: 306440484
• Report Number: 16077291
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EICA5874-01
• Device Catalogue Number: EICA5874-01
• Device Lot Number: 2100533
• 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: 12/09/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1825 DA
• Patient Sex: Male
• Patient Weight: 27 KG
• Patient Race: White