FDA.reportPublic FDA data

MAUDE MDR 2985873

MDR report key
2985873
Report number
9615010-2013-00003
Event key
0
Event type
3
Date of event
2013-01-28
Date received
2013-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
Address
5160 HACIENDA DR 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 AG (SITE OBERKOCHEN)JADPRS 500000001-5408-132NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-260

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT MULTIPLE ERRORS OCCURRED DURING THE START OF THE INTRAOPERATIVE RADIATION THERAPY (IORT) TREATMENT USING THE INTRABEAM MINIATURE THERAPEUTIC X- RAY DEVICE. AFTER SUCCESSFUL ATTEMPTS TO RESOLVE THE ERRORS, THE SURGEON MADE THE DECISION OT DISCONTINUE THE IORT TREATMENT. AT THIS POINT, 0.15 GY OF THE PRESCRIBED DOSE OF 20.00 GY HAD BEEN DELIVERED. THE TOTAL PROCEDURAL DELAY BETWEEN THE FIRST AND LAST ERROR MESSAGES WAS 51 MINUTES.

N

Patient 1

THE MFR'S REP INSPECTED THE INTRABEAM SYSTEM AND FOUND THAT ONE OF THE TRANSPORT LOCKS WAS NOT RELEASED. THE UNRELEASED TRANSPORT LOCK CONTRIBUTED TO A MISALIGNMENT OF THE APPLICATOR TIP. DETECTION OF TIP MISALIGNMENT WILL SHUT DOWN THE INTRABEAM SYSTEM AND GENERATE AN ERROR MESSAGE.