MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEURO CERVICAL

Catalog Number	DYNJ905045
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient undergoing neuro-cervical procedure developed a superficial left neck burn from cautery pencil.Per report, it was unsure what the issue with the cautery pencil was.The reported event immediately occurred during use of the cautery pencil on the patient.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.There was no information provided on the extent of the patient burn and what medical intervention was required.The sample was returned for evaluation.No issues with the cautery pencil when tested in cut or coagulation mode was identified.A root cause could not be determined at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient undergoing neuro-cervical procedure developed a superficial left neck burn from cautery pencil.

• Common Device Name: NEURO CERVICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7667883
• Report Number: 1423395-2018-00037
• Device Sequence Number: 751838
• Product Code: OJG
• UDI-Device Identifier: 10889942807284
• UDI-Public: 10889942807284
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ905045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/06/2018
• 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