MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PENCIL,CAUTERY,ROCKER,STERILE,LF,SS

Catalog Number ESRK3000

Device Problem Temperature Problem (3022)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

According to the facility on (b)(6)2023 "when turned on, bovie tip caught fire".

Manufacturer Narrative

According to the facility on (b)(6) 2023 "when turned on, bovie tip caught fire".Per the facility "bovie tip was in the air away from patient and when the md turned the bovie off the fire stopped".Per the facility the patient and provider were not injured related to the reported incident.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: PENCIL,CAUTERY,ROCKER,STERILE,LF,SS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18148946
• MDR Text Key: 328286617
• Report Number: 1417592-2023-00451
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10080196775972
• UDI-Public: 10080196775972
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ESRK3000
• Device Lot Number: 09522070008
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other