MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BIPOLAR CORD IN SPINE MODULE CDS

Catalog Number CDS984796C

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

During a spinal case the surgeon noted a smoke smell coming from the bipolar tool.The bipolar forceps was removed from use, when removing the product it was noted that the end of the cord that plugs into the forceps was black and charred.A second bipolar tool was obtained and the procedure continued without incident.The generator settings are unknown.No injury occurred to the patient and no medical intervention was required.Sample was not received, a root cause cannot be determined.Not returned.

Event Description

It was reported the bipolar cord smoked during use.

• Type of Device: BIPOLAR CORD IN SPINE MODULE CDS
• 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: 6394511
• MDR Text Key: 69572929
• Report Number: 1423395-2017-00004
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CDS984796C
• Device Lot Number: 16WB1837
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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