MAUDE Adverse Event Report: CONMED CORPORATION ABC; APPARATUS, ELECTROSURGICAL

Model Number 130321

Device Problems Defective Component (2292); Activation Problem (4042)

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

Event Date 04/09/2023

Event Type  malfunction  

Event Description

As per midas documentation, the argon beam was not working.The physician was pushing the buttons and it sounded like gas was coming out but the argon beam was not activating.The machine was troubleshooted by the staff and determined that the machine was working correctly.When the handpiece was replaced, it worked.

• Brand Name: ABC
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd.; utica NY 13502
• MDR Report Key: 17134692
• MDR Text Key: 317239388
• Report Number: 17134692
• Device Sequence Number: 1
• Product Code: HAM
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 130321
• Device Catalogue Number: 130321
• Device Lot Number: 20209034
• 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: 05/24/2023
• Date Report to Manufacturer: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA