MAXCESS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for MAXCESS manufactured by Nuvasive, Inc..

Event Text Entries

[135158244] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8309976
• MDR Report Key: 8309976
• Date Received: 2019-02-06
• Date of Report: 2019-01-15
• Date of Event: 2019-01-07
• Report Date: 2019-01-21
• Date Reported to FDA: 2019-01-21
• Date Reported to Mfgr: 2019-02-06
• Date Mfgr Received: 2019-03-25
• Date Added to Maude: 2019-02-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAXCESS
• Generic Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Product Code: KCT
• Date Received: 2019-02-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NUVASIVE, INC.
• Manufacturer Address: 101 ENTERPRISE STE 100 ALISO VIEJO CA 92656 US 92656

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-06