MAUDE MDR 8309976

MDR report key
8309976
Report number
8309976
Event key
0
Event type
3
Date of event
2019-01-07
Date received
2019-02-06
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAXCESSSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIESNUVASIVE, INC.KCT* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-060

Event Narratives#

D

Patient 1

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.