MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-LAP CHOLE PACK

Catalog Number	DYNJ55816
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer on 5/11, "during a surgery and while the surgeon was using the laparoscopic monopolar bovie, the thicker part of the single use bovie cord ignited a flame.".
Additional Manufacturer Narrative
According to the customer on 5/11, "during a surgery and while the surgeon was using the laparoscopic monopolar bovie, the thicker part of the single use bovie cord ignited a flame.The surgeon stopped the bovie and the flame vanished.The bovie cord, machine, adapter and pedal were removed and isolated.There was no harm to the patient, surgeon, or or team.The fire was visualized.There was no serious injury or medical intervention ".The device is not available 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: DBD-LAP CHOLE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19519347
• Report Number: 1423395-2024-00428
• Device Sequence Number: 6216268
• Product Code: FDE
• UDI-Device Identifier: 40889942578598
• UDI-Public: 40889942578598
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ55816
• Device Lot Number: 23JMH650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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