FDA.reportPublic FDA data

MAUDE MDR 3113970

MDR report key
3113970
Report number
9615010-2013-00011
Event key
0
Event type
3
Date of event
2013-04-15
Date received
2013-05-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACCOMBE
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTRABEAM SYSTEMSYSTEM, THERAPEUTIC, X-RAYCARL ZEISS MEDITEC AGJADPRS 500304534-7000-338NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-080

Event Narratives#

D

Patient 1

THE SITE REPORTED THAT DURING AN INTRAOPERATIVE RADIOTHERAPY (IORT) SURGICAL PROCEDURE, THEY ENCOUNTERED THE ERROR MESSAGE, "STEER ERROR", WITH THE CONCOMITANT SHUT DOWN OF THE INTRABEAM MINIATURE THERAPEUTIC X-RAY DEVICE. THE STAFF WERE ABLE TO PERFORM TROUBLESHOOTING AND RESTART THE IORT PROCEDURE. THE PROBLEM WAS ENCOUNTERED AND RESOLVED THREE MORE TIMES DURING THE IORT PROCEDURE. THE TOTAL PROCEDURAL DELAY WAS APPROXIMATELY 198 MINUTES. THE PRESCRIBED DOSE WAS SUCCESSFULLY ADMINISTERED TO THE PT. THIS IS INFORMATION FOR PT 1 OF 2.

N

Patient 1

THE MANUFACTURER'S REPRESENTATIVE INSPECTED THE INTRABEAM SYSTEM ON-SITE AND FOUND HE COULD REPRODUCE THE PROBLEM WHEN USING THE INTRABEAM MINIATURE X-RAY SOURCE (XRS) IN AN UPSIDE DOWN MODE. THE XRS WAS EXCHANGED FOR ANOTHER AND RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE INTRABEAM AUTOMATIC BEAM CENTERING (ABC) CONTROLS THE ELECTRON BEAM POSITIONING TO MANUFACTURER'S SPECIFICATIONS. WHEN THE BEAM POSITION EXCEEDS TOLERANCES, THE SYSTEM DISPLAYS AN ERROR MESSAGE AND THE XRS IS AUTOMATICALLY TURNED OFF. TROUBLESHOOTING AND ERROR MESSAGES ARE DISCUSSED IN THE USER MANUAL.