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

Model Number PLPUL2020

Device Problem Defective Device (2588)

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

Event Date 12/14/2021

Event Type  malfunction  

Event Description

Ultra plumepens not heating up/intermittently working.

• Brand Name: PLUMEPEN
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 13235686
• MDR Text Key: 283669193
• Report Number: 13235686
• 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: 12/29/2021

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 Model Number: PLPUL2020
• Device Catalogue Number: PLPUL2020
• Device Lot Number: 600621; 072021
• 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: 12/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1