MAUDE MDR 313183

MDR report key
313183
Report number
313183
Event key
0
Event type
3
Date of event
2001-01-05
Date received
2001-01-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1DYONICSFO LIGHT SOURCESMITH & NEPHEW DYONICSFCRABI 11**NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-01-1901. O

Event Narratives#

D

Patient 1

PT UNDERWENT DIRECT LARYNGOSCOPY WITH VOCAL CORD BIOPSY DUE TO ENDOLARYNGEAL LESIONS. THE LESION WAS PHOTO DOCUMENTED BY PASSING THE 4MM NASAL TELESCOPE THROUGH THE DIDO LARYNGOSCOPE. LIGHT CORD CONNECTION TO SCOPE WAS "HOT". AT CONCLUSION OF THE PROCEDURE, THE ROOM LIGHTS WERE BRIGHTENED AND DRAPES WERE REMOVED, IT BECAME EVIDENT THAT THE PT SUSTAINED A PARTIAL THICKNESS BURN TO THE NASAL TIP SKIN. NO OTHER INJURY WAS IDENTIFIED. SILVADENE CREAM WAS THEREAFTER APPLIED TO THE AREA. FINDINGS AND MANAGEMENT OF THIS COMPLICATION WAS FULLY DISCUSSED WITH PT AND PT'S SPOUSE. PT WILL BE FOLLOWED UP BY MD IN OFFICE. MD WAS NEW TO THIS HOSP AND WAS UNAWARE THAT HOSP WAS ONLY "HOT" LIGHT SOURCES IN THE OPERATING ROOM. THIS LIGHT SOURCE WAS COMPARED TO A SECOND LIKE LIGHT SOURCE AND WAS FELT TO BE WARMER THAN USUAL AT CONNECTOR TO SCOPE. BIOMEDICAL ENGINEER EXAMINED DEVICE AND FOUND NO DEFECT OR PROBLEM WITH EQUIPMENT. DYONICS REP CONTACTED AND, AFTER SIGNING A RELEASE FORM, TOOK THE EQUIPMENT FOR EVALUATION ON 01/08/2001, OBSERVED NO PROBLEMS ON INITIAL EVALUATION.