FDA.reportPublic FDA data

MAUDE MDR 6288864

MDR report key
6288864
Report number
8010047-2017-00100
Event key
0
Event type
3
Date of event
2017-01-06
Date received
2017-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR HIROKI MORIYAMA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US
Phone
814-814-8142
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDICAL CONTROL UNIT FOR ENDOSURGERYSYSTEM INTEGRATIONOLYMPUS MEDICAL SYSTEMS CORP.ODAUCES-3Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-310

Event Narratives#

N

Patient 1

THE SUBJECT UCES-3 WAS RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS CHECKED THE SUBJECT UCES-3, AND THERE WAS NO ABNORMALITY OF THE SUBJECT DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

DURING THE UNSPECIFIED LAPAROSCOPIC SURGERY, THE USER FACILITY COULD NOT OPERATE DEVICES, BECAUSE AN IMAGE OF A MAIN MONITOR AND A SUB MONITOR OF THE ENDOALPHA SYSTEM DISAPPEARED. THE USER FACILITY REPLACED THE SUBJECT SYSTEM INCLUDING UCES-3 WITH ANOTHER UNSPECIFIED SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN REPLACING THE DEVICE. WHEN THE SUBJECT SYSTEM WAS CHECKED AFTER THE PROCEDURE, THERE WAS NO ABNORMALITY OF THE SUBJECT SYSTEM. THE USER FACILITY SUSPECTS THE SUBJECT UCES-3 WHICH CONTROLS THE 2 MONITORS TO DISPLAY IMAGES MIGHT HAVE ANY ABNORMALITY.