MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MINOR PROCEDURE PACK-LF

Catalog Number	DYNJ35745F
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on 11/02/2023 the cautery tip caught fire and was immediately removed from the surgical site and extinguished.
Additional Manufacturer Narrative
According to the facility on 11/02/2023 the cautery tip caught fire and was immediately removed from the surgical site and extinguished.Per the facility there was no harm to the patient or 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: MINOR PROCEDURE PACK-LF
• 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: 18192832
• Report Number: 1423395-2023-00073
• Device Sequence Number: 20468517
• Product Code: FDE
• UDI-Device Identifier: 10888277782112
• UDI-Public: 10888277782112
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/22/2023

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 Catalogue Number: DYNJ35745F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/22/2023
• 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