MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; CHEST BREAST - NTSC

Catalog Number DYNJ907410

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was undergoing a breast reconstruction, and 10 minutes into the procedure there was a spark from inside the cautery pencil casing a burn to the patient.It is unknown what angle the device was being used at the time of the spark but it was confirmed that the tip was firmly seated in the device at the time of the incident.The burned tissue was removed and the surgery was continued without incident.There was no reported serious injury or follow up medical care required related to the reported incident.The patient is reportedly doing fine.No actual sample is available to be returned for evaluation.No additional information is available.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.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 Description

It was reported that a patient was undergoing a breast reconstruction, and 10 minutes into the procedure there was a spark from inside the cautery pencil casing a burn to the patient.

• Type of Device: CHEST BREAST - NTSC
• 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: 11187825
• MDR Text Key: 227486310
• Report Number: 1423395-2021-00006
• Device Sequence Number: 1
• Product Code: FTN
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2021

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: Health Professional
• Device Catalogue Number: DYNJ907410
• Device Lot Number: 20JBI007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/18/2021
• 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: 34 YR
• Patient Weight: 57