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

Catalog Number	DYNJ59457B
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.

• Common Device Name: 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
• Report Number: 1423395-2023-00065
• Device Sequence Number: 6849028
• Product Code: OHM
• UDI-Device Identifier: 10195327446574
• UDI-Public: 10195327446574
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown