MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY DEVICE IN HIP TOTAL JOING PACK

Catalog Number DYNJ27840I

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The account reported that a cautery pencil caught fire during a procedure.The cautery device was sitting in a holster cup that was sitting in a pouch attached to the drape.The cautery device had been in use intermittently for an hour and a half and was not in use when the fire started.It is unknown how the fire was extinguished.No injury occurred to patient or staff and no medical intervention was required.A sample was returned and a root cause has not been determined.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported a cautery pencil caught on fire.

• Type of Device: CAUTERY DEVICE IN HIP TOTAL JOING PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6629214
• MDR Text Key: 77354019
• Report Number: 1423395-2017-00014
• Device Sequence Number: 1
• Product Code: OJH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ27840I
• Device Lot Number: 17MB7046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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