FDA.reportPublic FDA data

MAUDE MDR 5694212

MDR report key
5694212
Report number
5694212
Event key
0
Event type
3
Date of event
2016-05-25
Date received
2016-06-02
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
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
1CALLISTOTOMOGRAPHY, OPTICAL COHERENCECARL ZEISS MEDITEC AGOBO* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-020

Event Narratives#

N

Patient 1

D

Patient 1

THE CALISTO MACHINE WAS PLACED IN ONE OF THE OPERATING ROOMS. THE SURGEON WAS NOT ABLE TO GET AN IMAGE. THE STAFF ATTEMPTED TO SOLVE THE ISSUES WITH MANY ATTEMPTS BUT WERE UNSUCCESSFUL. THE OTHER CALISTO WAS PLACED IN THE ROOM, BUT THEN ALL THE INFORMATION FROM THE USB PORT WAS LOST WHEN IT WAS PLACED IN THE FIRST CALISTO MACHINE. THE STAFF WENT BACK TO THE CLINIC TO INSTALL ALL THE PATIENT INFORMATION INTO THE USB PORT AND THEN COME BACK TO OPERATING ROOM, CAUSING A 30 MINUTE DELAY. THE SURGEON NOTIFIED THE PATIENT OF THE ISSUE. THE SURGERY THEN CONTINUED AS NORMAL. IT WAS LATER DETERMINED THAT THE SOFTWARE WAS NOT INSTALLED; THE VENDOR INSTALLED.