FDA.reportPublic FDA data

MAUDE MDR 1564735

MDR report key
1564735
Report number
MW5014048
Event key
0
Event type
3
Date of event
2009-12-17
Date received
2009-12-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANCED STERILIZATION PRODUCTSAUTOMATIC ENDOSCOPE REPROCESSORJOHNSON AND JOHNSONNVE387P - 2NANA Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-180

Event Narratives#

D

Patient 1

WHILE CLEANING AN ENDOSCOPE, THE TECH NOTED THE DEVICE (ASP AUTOMATIC ENDOSCOPE REPROCESSOR) TO BE RUNNING HOT. SHE CALLED THE CHARGE NURSE TO THE UNIT AND WHEN SHE FELT THE LID, IT WAS EXTREMELY HOT. SHE STOPPED THE CLEANING CYCLE AND CALLED BIOMED. BIOMED CAME INTO THE ROOM AND LIFTED UP THE LID AND STEAM CAME UP AND WHEN HE CHECKED THE SOLUTION TEMP, IT WAS AROUND 107 DEGREES. THE FUMES FROM THE CIDEX OPA WENT INTO THE AIR AND CAUSED SOME EYE IRRITATION/LIGHT HEADEDNESS. STAFF REMOVED FROM AREA. DEVICE WAS TAKEN OUT OF SERVICE AND CONTAINED IN A SECURE AREA. THE ASP COMPANY WAS CALLED AND A MESSAGE WAS LEFT FOR ADVANCED STERILIZATION PRODUCTS REP. A RETURN CALL FROM THE COMPANY CAME LATER ON THE DAY OF THE EVENT.