FDA.reportPublic FDA data

MAUDE MDR 2291655

MDR report key
2291655
Report number
9615058-2009-00002
Event key
0
Event type
3
Date of event
2009-11-20
Date received
2011-05-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ORI LUBIN, MANAGER
Address
5 NAHUM HETH ST. P.O. BOX 2039 TIRAT CARMEL 31290 IS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EXABLATE 2000MRGFUSINSIGHTEC, LTD.NRZEXABLATE 2000* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-310

Event Narratives#

D

Patient 1

STOP SONICATION ON CONSOLE FAILED TO OPERATE. IN THIS EVENT THE PHYSICIAN USED THE STOP SONICATION BUTTON TO LITERALLY STOP THE SONICATION AND NOT AS AN EMERGENCY BUTTON. THE EXECUTED SONICATION WAS SAFE THUS ABSOLUTELY NO HARM TO PATIENT.

N

Patient 1

THE STOP SONICATION ASSEMBLY HAS BEEN AVAILABLE IN ITS CURRENT FORM ALMOST FROM THE BEGINNING OF THE USE OF THE EXABLATE AND THIS IS THE FIRST TIME IN PROBABLY AROUND 5000 TREATMENTS THAT SUCH A DEFECT HAS BEEN REPORTED. ALTHOUGH IN THIS CASE NO ADVERSE EVENT HAPPENED, SINCE THIS IS AN EMERGENCY SAFETY FEATURE, ITS FAILURE IS UNACCEPTABLE. COMPANY SENT AN APPLICATION NOTE TO ALL SITES. THE NOTE REQUIRES THE USERS TO PRESS THE STOP SONICATION BUTTON DURING POWER-UP FOR THE DAILY QUALITY ASSURANCE (DQA) TESTING. THIS ACTION SHOULD ONLY TAKE A FEW SECONDS AND SHOULD COMPLETELY PREVENT THE MALFUNCTION FROM HAPPENING DURING TREATMENT SINCE COMPANY CANNOT ENVISAGE ANY SCENARIO WHERE THE STOP BUTTON FAILS SPONTANEOUSLY DURING TREATMENT.