MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC (NORTHPOINT SERVICES) NEURO BASIC CUSTOM PACK; CUSTOM SURGICAL PACK

Model Number ES0012M

Device Problem Fire (1245)

Patient Problem No Information (3190)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

Surgical fire resulted from the electrocautery pencil from neuro basic custom pack.The procedure had started and the first incision was made.The procedure had started and the first incision was made.Dr () and dr () were both scrubbed into surgery together.After the incision, the rn, handed both dr () and dr () instruments necessary for the take down process of the surgery.Dr () was handed the bovie to accomplish the take down.After using the bovie for a couple of minutes, dr () had put the surgical pencil back into the pouch until his next use.Another rn went to turn on the warming blanket machine to keep the patient warm.After rn pushed the button, the warming blanket inflated and dr () acted surprised.Both rns asked what was the problem as both thought dr () didn't know why the warming blanket inflated.Dr () then stated, "the surgical pencil caught fire!" nurse () asked if it caught fire or if it sparked and then dr () stated it caught fire.Dr () grabbed the surgical pencil and raised it in the air after he said, "it went out after 2 seconds by itself." nurse () then asked if he wanted a whole new surgical pencil or just the pencil tip itself and dr () stated both.Nurse () and nurse () then replaced the entire pencil and tip and sent the "defective" surgical pencil to () for further inspection.

• Brand Name: NEURO BASIC CUSTOM PACK
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC (NORTHPOINT SERVICES); 1160 s. northpoint blvd.; waukegan IL 60085
• MDR Report Key: 7780279
• MDR Text Key: 117016568
• Report Number: 7780279
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ES0012M
• Device Catalogue Number: ES0012M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1