MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; CAUTERY DEVICE IN DBD-T A UM-LF

Model Number	DYNJ902326A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a tonsillectomy procedure, an "abnormality" with the cautery device was identified and a patient experienced an oral commissure burn.The reporting facility was unable to specify what cautery device "abnormality" was identified.An intraoperative plastics consult was obtained after noticing the oral commissure burn, however, no medical intervention was reported.A new cautery device was obtained and no further incident was reported.The patient was discharged home with no reported impact to length of stay.Application of bacitracin ointment was prescribed for the patient and the patient's oral commissure burn has reportedly fully healed.The cautery device was reportedly discarded and no sample was available to be returned for evaluation.A root cause was unable to be determined.Due to the reported burn and need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient experienced a burn during use of the cautery device.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CAUTERY DEVICE IN DBD-T A UM-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11724398
• Report Number: 1423395-2021-00023
• Device Sequence Number: 3080884
• Product Code: LRO
• UDI-Device Identifier: 10889942714933
• UDI-Public: 10889942714933
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: DYNJ902326A
• Device Catalogue Number: DYNJ902326A
• Device Lot Number: 20BBP973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 15