MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; PENCIL, CAUTERY, PUSH BUTTON, PTFE

Model Number	ESPB3002P
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 during a tonsillectomy and adenoidectomy a burn injury occurred on the patient's right lip while using a cautery pencil.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 during a tonsillectomy and adenoidectomy a burn injury occurred on the patient's right lip while using a cautery pencil.Per the facility the burn happened after removal of the left tonsil and there was 'char noted where the cautery tip was attached to the hand piece'.Per the facility, 'the cautery tip was checked and it appeared to be completely inserted without any loose gases'.According to the facility the burn injury was superficial, and 1% lidocaine with epinephrine was given for postoperative/burn pain management.Bacitracin was then applied to the burn.Per the facility the patient is reported to be doing fine and there was no impact to the procedure or staff.The sample is available and is pending evaluation.No additional information is available.Due to the reported incident and 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.

• Brand Name: Medline
• Common Device Name: PENCIL, CAUTERY, PUSH BUTTON, PTFE
• 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: 14525485
• Report Number: 1417592-2022-00069
• Device Sequence Number: 5164769
• Product Code: GEI
• UDI-Device Identifier: 10193489017724
• UDI-Public: 10193489017724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ESPB3002P
• Device Catalogue Number: ESPB3002P
• Device Lot Number: 09521110013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Male