MAUDE Adverse Event Report: CONMED CORPORATION MACROLYTE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 440-2400

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Attempted to use bovie with macrolyte premie bovie pad but rem pad alert signal came on and bovie would not work.New bovie pad applied and changed bovie machine, but same response.Changed to covidien valleylab infant bovie pad and bovie was functional.

• Brand Name: MACROLYTE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 12868363
• MDR Text Key: 281219018
• Report Number: 12868363
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 440-2400
• Device Catalogue Number: 440-2400
• Device Lot Number: 202109205
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 DA
• Patient Sex: Male