MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PENCIL,CAUTERY,PUSHBUTTON,STERILE,LF,SS

Catalog Number	ESPB3000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a coronary artery bypass graft and bilobectomy procedure the cautery pencil sparked and smoked.It is unknown at what point in the procedure the reported incident occurred.It is unknown if the reported incident occurred during first or subsequent use of the cautery pencil.The facility contact was unable to provide information on the used, mode, and settings of the cautery pencil at the time of the reported incident and which part of the cautery pencil experienced the sparking and smoking.The facility contact was unable to provide information on the model, mode, and settings of the generator that was in use at the time of the reported incident.It is unknown if the facility's staff continued to use the same cautery pencil after noticing the reported sparking and smoking.The patient was under general anesthesia at the time of the incident.The overall procedure did not last longer than expected and the patient did not require additional anesthesia during the procedure.The facility contact noted that there was no impact or adverse effect to the patient, to the procedure, or to a staff member.The facility contact noted that there was no serious injury, medical intervention, or follow-up care related to the reported incident.A sample was returned to the manufacturer for evaluation.The sample was noted to be used and the cautery tip was not insulated which may allow the entire cautery tip to conduct.Functional inspection was performed on the returned sample and the reported product issue was not confirmed.The sample functioned as intended.A root cause for the reported incident could not be 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 a coronary artery bypass graft and bilobectomy procedure the cautery pencil sparked and smoked.

• Common Device Name: PENCIL,CAUTERY,PUSHBUTTON,STERILE,LF,SS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8078337
• Report Number: 1417592-2018-00118
• Device Sequence Number: 13841199
• Product Code: GEI
• UDI-Device Identifier: 10080196775934
• UDI-Public: 10080196775934
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: ESPB3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/16/2018
• 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: 80 YR
• Patient Weight: 72