FDA.reportPublic FDA data

MAUDE MDR 2516489

MDR report key
2516489
Report number
2523209-2012-00001
Event key
0
Event type
3
Date of event
2012-03-12
Date received
2012-03-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
144 RAILROAD DR. IVYLAND PA 18974 US
Phone
215-215-2153
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 83 PLUSULTRASONIC WASHER HIGH LEVEL DISINFECTORCUSTOM ULTRASONICSNVE83 PLUS 283+22586, 2586-1R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-2901. O

Event Narratives#

D

Patient 1

IT WAS REPORTED BY (B)(6) HOSPITAL THAT A TECH WAS USING AN "F6" "WASH-ONLY" FUNCTION ON THE SYSTEM 83 PLUS, BYPASSING THE TERMINAL "F7" "WASH- DISINFECT CYCLE. IT WAS ALSO DETERMINED THAT THE "F6" SAFETY COVER WAS REMOVED BY OPERATOR, USING THE DEVICE OFF-LABEL, AND NOT FOLLOWING THE MFR'S SPECIFICATIONS AND LABEL WARNING. THE TECHNICIAN HAD BEEN DOING THIS FOR APPROX A MONTH. SINCE UPPER AND LOWER GI ENDOSCOPES WERE IMPROPERLY PROCESSED IN THE SYSTEM 83. THERE IS LOW RISK OF DISEASE TRANSMISSION. A RISK ASSESSMENT HAS BEEN PROVIDED TO THE HOSPITAL AND WILL ACCOMPANY THE FILING.