MAUDE Adverse Event Report: CONMED CORPORATION PLUMPEPEN ULTRA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLPUL2020

Device Problem Self-Activation or Keying (1557)

Patient Problem Burn, Thermal (2530)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Bovie fired without being activated resulting in two burns to the patient.Fda safety report id # (b)(4).

• Brand Name: PLUMPEPEN ULTRA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 11229199
• MDR Text Key: 228963851
• Report Number: MW5099000
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLPUL2020
• Device Lot Number: 280720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR