MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CUSTOM BASIC PACK

Catalog Number	DYNJ0773958M
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the covidien cautery device caught on fire during formalization of right below the knee amputation (bka) procedure.According to the facility the device was in use for less than 5 minutes with no flammable agents involved in the reported incident.It was noted that the device was being used superficially and the electrode tip produced a flame.The flame was extinguished and the hand piece and generator were replaced.No flame made contact with the patient.There was no serious injury related to this report.The settings of the device at the time of the incident were noted to be cut: 50, pure; coag: 50, fulgurate and set at intermittent.No impact or adverse effect to the patient, to the procedure, or to a staff member was reported to the procedure pack manufacturer.The actual sample involved in the incident was not returned to the manufacturer for evaluation.Due to the reported fire, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tip of the covidien cautery device caught on fire.

• Common Device Name: CUSTOM BASIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10908901
• Report Number: 1423395-2020-00039
• Device Sequence Number: 910359
• Product Code: LRO
• UDI-Device Identifier: 10193489270952
• UDI-Public: 10193489270952
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0773958M
• Device Lot Number: 20HKB705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 91