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

Catalog Number	ESRK3000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6)2023 "when turned on, bovie tip caught fire".
Additional 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.

• Common Device Name: 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
• Report Number: 1417592-2023-00451
• Device Sequence Number: 7502902
• Product Code: GEI
• UDI-Device Identifier: 10080196775972
• UDI-Public: 10080196775972
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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 Catalogue Number: ESRK3000
• Device Lot Number: 09522070008
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown