MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; BASIC SET-UP

Catalog Number DYNJS0105

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer was undergoing a bilateral breast augmentation procedure and experienced a burn from the cautery device.During cauterization of an incision the patient experienced a burn to the skin directly below the right breast.According to the reporter the breast had been prepped with chloraprep and it was well over the necessary time required for drying.It was noted that the tip of the cautery device was not firmly seated in the device which was being used at a 15-30 degree angle.The cautery tip sparked and one of the team members called a burn incident to draw attention to the matter.The surgeon reported that the tip was not firmly seated, yet when the cautery button was pushed the device still activated.The tip not being firmly seated caused the cautery tip to spark/arch at the base where it was not completely seated and burn the patient.There was no serious injury noted.The burn was small and near the incision line so the surgeon was able to excise the burned tissue without further intervention.The facility was using a covidien/valleylab ft10.The generator was set at 30/30 for cut/cautery.The generator was in use for approximately 5min prior to a teammate noticing the burn.The customer did return photos for evaluation however it was not possible to perform testing on the photos to evaluate the customer reported issue.There was no actual sample returned for evaluation.Should the physical sample be received by the manufacturer, a full investigation will be conducted.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the customer was undergoing a bilateral breast augmentation procedure and experienced a burn from the cautery device.

• Type of Device: BASIC SET-UP
• 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: 11148170
• MDR Text Key: 226066256
• Report Number: 1423395-2021-00001
• Device Sequence Number: 1
• Product Code: LRO
• 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: 01/11/2021

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
• Device Operator: No Information
• Device Catalogue Number: DYNJS0105
• Device Lot Number: 20ABU675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA 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): Required Intervention
• Patient Age: 23 YR