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

Catalog Number DYNJ905045

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 06/13/2018

Event Type  Injury  

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 Description

It was reported that the patient undergoing neuro-cervical procedure developed a superficial left neck burn from cautery pencil.

• Type of Device: NEURO CERVICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7667883
• MDR Text Key: 113388287
• Report Number: 1423395-2018-00037
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10889942807284
• UDI-Public: 10889942807284
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ905045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other