MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; C-SECTION SMMC

Catalog Number DYNJ59457B

Device Problem Temperature Problem (3022)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2023

Event Type  Injury  

Event Description

According to the facility on 10/09/23 there was a fire that occurred in the operating room related to the use of a cautery pencil.

Manufacturer Narrative

According to the facility, on (b)(6) 2023 there was a fire that occurred in the operating room related to the use of a cautery pencil.Per the facility there was a flame "like when you light a big match".Per the facility in their opinion "the device did not malfunction, however, because it had a different coated tip, when used during the procedure it caused a flame".Per the facility the patient was not burned and there was no harm to the staff.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.

• Type of Device: C-SECTION SMMC
• 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: 18030790
• MDR Text Key: 326864411
• Report Number: 1423395-2023-00065
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10195327446574
• UDI-Public: 10195327446574
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2023

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
• Device Catalogue Number: DYNJ59457B
• Device Lot Number: 23HMG293
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other