MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; ENS. UROLOGIE LAPAROTOMIE-LF

Model Number	DYNJ53114C
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, when using a cautery device during a procedure the "cautery caught fire" at the end of the procedure.
Additional Manufacturer Narrative
According to the customer, when using a cautery device during a procedure the "cautery caught fire" at the end of the procedure.The customer reported there was no injury to the patient and no medical intervention.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: ENS. UROLOGIE LAPAROTOMIE-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17353720
• Report Number: 1423395-2023-00034
• Device Sequence Number: 20350598
• Product Code: FDE
• UDI-Device Identifier: 10195327096816
• UDI-Public: 10195327096816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: DYNJ53114C
• Device Catalogue Number: DYNJ53114C
• Device Lot Number: 22HBM506
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 07/19/2023
• 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 Sex: Unknown