MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 01/07/2019

Event Type  malfunction  

Event Description

The light source used (from the nuvasive maxcess surgical access kit) was plugged into the light box by the rn and then the staff noticed smoking and a burning smell coming from the light box at the point where the light source was plugged in.At this point, i am back from break and the nuvasive representative was bringing in another kit to use the light source out of it.The rn had already removed the light box from the room and brought in a different one.When she went to plug in the second light source the other representative said to hold off plugging it in because some light boxes have caused the metal end that gets inserted into the box to overheat "and there's an adaptor we are getting for you, so hold off a sec".They gave us the adaptor, we plugged it in and no further problems were noted.Both the light box and the cord were sent to biomed.Operating room leadership review: investigation summary: nurse in the room notified me that the light source was smoking from the port where the light cord was plugged in.Light cord was part of a kit supplied by nuvasive.Nuvasive rep told staff in the rooms that this occurs occasionally and that an adaptor was needed for our light source.Nurse was instructed to disconnect the light cord from the light source and take both items out of use immediately, then to save all packaging and the cord itself and put in a work order for the light source.Light source, cord, and packaging were taken to the biomed office for evaluation.Why did this happen? issue with light cord.

• Brand Name: MAXCESS
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): NUVASIVE, INC.; 101 enterprise ste 100; aliso viejo CA 92656
• MDR Report Key: 8309976
• MDR Text Key: 135158244
• Report Number: 8309976
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2019,01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA