MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP TONSIL PACK

Model Number	DYNJ908452
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the facility that during the beginning of a tonsillectomy /adenoidectomy, the surgeon stated that when he activated the bovie he witnessed a visible flame for a split second and removed the device from service.The surgical team changed the bovie pencil, tip, cautery pad and electrocautery machine before carrying on with the procedure.There was reportedly no visible injury to the patient and no impact on the procedure being performed, the procedure was able to be completed.It was reported that the device was set to 30 cut/30 coag.No additional information is available.A sample was received for evaluation.The customer returned one cautery pencil and cautery tip as a sample for our investigation.The rest of the pack was not received at this time.The end user reportedly noted a flame coming from the bovie tip.The sample was observed with dark char on the end of the cautery tip and the clear insulation appears slightly deformed, a definitive root cause was not able to be established.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.
Event or Problem Description
It was reported that during the beginning of a tonsillectomy/adenoidectomy, the surgeon noticed a small flame at the tip of the bovie when he activated the device.No injury was noted to the patient, the device was immediately removed from service and replaced with a new bovie pencil.

• Brand Name: TONSIL PACK
• Common Device Name: TONSIL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14776779
• Report Number: 1423395-2022-00024
• Device Sequence Number: 12030554
• Product Code: OGR
• UDI-Device Identifier: 10195327073602
• UDI-Public: 10195327073602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ908452
• Device Catalogue Number: DYNJ908452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 18 KG