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

Model Number DYNJ53114C

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2023

Event Type  Injury  

Event Description

According to the customer, when using a cautery device during a procedure the "cautery caught fire" at the end of the procedure.

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.
• Type of Device: 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
• MDR Text Key: 319333847
• Report Number: 1423395-2023-00034
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327096816
• UDI-Public: 10195327096816
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ53114C
• Device Catalogue Number: DYNJ53114C
• Device Lot Number: 22HBM506
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other