MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; MAJOR BASIN PACK

Catalog Number DYNJ16474C

Device Problem Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient suffered a minor burn at the incision site when the cautery device arched during the procedure.It is unknown if any medical treatment was indicated, however the procedure continued without incident.We received very little information.The cautery device was returned for evaluation.Upon visual inspection, it was noted that the cable on the cautery device was cut.We were unable to evaluate the actual sample.Unused samples from inventory were tested in both the cut and coag modes using varied generator settings and cycles.A root cause was not determined.We were unable to duplicate the reported concern.Due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

The patient suffered a minor burn from the cautery device.

• Type of Device: MAJOR BASIN PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5451299
• MDR Text Key: 38693232
• Report Number: 1423395-2016-00015
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ16474C
• Device Lot Number: 15KB9110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other