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

Catalog Number	ESPB3000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a laparotomy with bilateral salpingooophorectomy the tip of the cautery device caught fire.It is unknown if the cautery device was being used at the time of this incident.It is unknown if this occurred during the first use of the cautery device.Reportedly, the fire was put out and there was no impact to the patient or to the procedure.It was reported that there was no injury to the patient or to a staff member related to this incident.The cautery device was set at 50 cut and 50 coag at the time of the fire.The settings of the generator are unknown.Per the facility, the cautery device settings were changed to 40 cut and 40 coag following the fire and the procedure was completed with the same device with no further incident reported.The patient was under general anesthesia at the time of the incident.The procedure did not last longer than expected and the patient did not require additional anesthesia to complete the procedure.The facility indicated that no sample is available to be returned to the manufacturer for evaluation.A root cause could not be determined.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 during a laparotomy with bilateral salpingooophorectomy the tip of the cautery device caught fire.

• 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: 7773338
• Report Number: 1417592-2018-00080
• Device Sequence Number: 13843180
• Product Code: GEI
• UDI-Device Identifier: 10080196775934
• UDI-Public: 10080196775934
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/10/2018

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: ESPB3000
• Device Lot Number: 35317110012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/10/2018
• 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: 52 YR
• Patient Weight: 72