FDA.reportPublic FDA data

MAUDE MDR 6983254

MDR report key
6983254
Report number
1220246-2017-00405
Event key
0
Event type
3
Date of event
2017-09-28
Date received
2017-10-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIK BAJNATH, ADVERSE EVENTS
Address
1370 CREEKSIDE BOULEVARD NAPLES FL 34108 US
Phone
800-800-8009
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FUSED UNI LIGHT CABLE,3.5MMX 274CM,GRLIGHT, SURGICAL, FIBEROPTICARTHREX INC.FSTAR-3240-3530WO133554Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2701. O

Event Narratives#

N

Patient 1

PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF TWO SUBMISSIONS FROM THE SAME EVENT. THE OTHER ONE IS CC126477-LINE 208954-00404. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPALINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION REVEALED THAT THE RETURNED "HOT LIGHT GUIDES" HAVE SIGNIFICANT PROXIMAL END GLASS ATTACK. THE CLAD GLASS IS MISSING AND THE POLISHED FIBER IS SIGNIFICANTLY RECESSED. SIGNIFICANT THERMAL ENERGY ABSORPTION HAS DISCOLORED THE PROXIMAL END TIP. TRANMISSION IS HALF OF THE OLDER REFERENCE LIGHT GUIDE TO NO OUTPUT ON THE LOT NUMBER WO132759 LIGHT GUIDE. INEFFICIENT TRANSMISSION WILL INDUCE MORE ABSORPTION TO THE SURROUNDING METAL MAKING IT HOT TO THE TOUCH. THE CAUSE OF THE EVENT IS UNDETERMINED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THE LIGHT-TRANSITION CABLE GETS HEATED TO OVER 90?C (194?F) AFTER 1-2 MIN ON THE SIDE THAT IS CONNECTED TO THE LIGHT SOURCE. AT THE SAME TIME A BURNED MATERIAL SMELL WAS RELEASED BY THE DEVICE THROUGH THE VENTILATION. THE HEATING ALSO APPEARS WITH A NEW CABLE FROM THE SAME ARTICLE.THE NURSE TOUCHED AND REMOVED THE WIRE AND INCURRED A BURN INJURY - SMALL BURN BLISTER.