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

Model Number ASHA4250-01

Device Problem Defective Component (2292)

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

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Defective et error code.

• 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: 11737004
• MDR Text Key: 247695181
• Report Number: 11737004
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/19/2021

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 Model Number: ASHA4250-01
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2067276
• 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: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1