MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY DEVICE IN NEURO BASIC

Catalog Number	DYNJ46424C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an anterior cervical diskectomy and fusion at cervical 6-7 with c-arm, the cautery device caught fire.Reportedly, at the time of the fire, the cautery device had been put "back into the pouch until next use." this incident occurred after the cautery device was initially used.According to the facility, the fire "went out after 2 seconds by itself." it was not identified which part of the device caught on fire.A new cautery device and tip were obtained and the procedure was completed without further reported incident.The patient was under general anesthesia at the time of this incident.There was no reported increase in overall procedure time or need for additional anesthesia.The facility did not identify if the cautery device had been on cut or coag mode prior to the incident.The generator's make, model, settings, and mode were not identified by the facility.There was no reported impact to the patient, to a staff member, or to the procedure.The cautery device was returned to the manufacturer for evaluation.The cautery device functioned nominally in both cut and coag modes.The cautery device shut off immediately after the push button was released.There was no fire or delay in functionality noted during sample investigation.The reported product issue could not be confirmed.A root cause could not determined.Due to the reported incident, 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 during an anterior cervical diskectomy and fusion at cervical 6-7 with c-arm, the cautery device caught fire.

• Common Device Name: CAUTERY DEVICE IN NEURO BASIC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7823573
• Report Number: 1423395-2018-00045
• Device Sequence Number: 1940545
• Product Code: OJG
• UDI-Device Identifier: 10889942583812
• UDI-Public: 10889942583812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: DYNJ46424C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 84