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

Model Number EICA5872-01

Device Problem Suction Failure (4039)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

Lawson 224585, ref eica5872-01, evac 70 xtra would not suction, per surgeon.

• 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: 15851683
• MDR Text Key: 304202517
• Report Number: 15851683
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EICA5872-01
• Device Catalogue Number: EICA5872-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Sex: Male