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

Model Number DYNJ902326A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/11/2021

Event Type  malfunction  

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 Description

It was reported that a patient experienced a burn during use of the cautery device.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CAUTERY DEVICE IN DBD-T A UM-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11724398
• MDR Text Key: 249664253
• Report Number: 1423395-2021-00023
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942714933
• UDI-Public: 10889942714933
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ902326A
• Device Catalogue Number: DYNJ902326A
• Device Lot Number: 20BBP973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 15