MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; PENCIL,CAUTERY,ROCKER,PTFE,STERILE

Catalog Number ESRK3002

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/26/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by the facility that a surgeon reported that he got a shock from a cautery pencil during a patient procedure.The surgeon was reportedly performing a laparoscopic cholecystectomy and while using the pen he felt an electric current run down his spine.The surgeon is unsure what caused the feeling of shock but is thinking it may have come from the pencil.The pencil was taken out of service and discarded.There was no follow up medical attention required related to the customer reported issue.The reporter is unsure how long the product was in use, if there were any flammable agents in use, if the tip was firmly seated, if there were any sparks on the pencil prior to the event or what the settings were on the generator.The sample is not available to be returned to the manufacturer for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported by the facility that a surgeon reported that he got a shock from a cautery pencil during a patient procedure.

• Type of Device: PENCIL,CAUTERY,ROCKER,PTFE,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11238711
• MDR Text Key: 233438439
• Report Number: 1417592-2021-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ESRK3002
• Device Lot Number: 35319120033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other