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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALIL MEDICAL LTD. PRESICE CRYOABLATION SYSTEM; CYROSURGICAL UNIT, ACCESSORIES
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GALIL MEDICAL LTD. PRESICE CRYOABLATION SYSTEM; CYROSURGICAL UNIT, ACCESSORIES Back to Search Results
Model Number FPRCH2047
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2014
Event Type  malfunction  
Event Description
The monitor went blank during a renal cryoablation treatment after a 5 min freeze cycle.The monitor wires and power cord were plugged in securely.The system was turned off for 2-3 min and turned back on, but the monitor still not working.The site used a backup machine to finish the procedure.The pt under anesthesia longer than expected, but was unharmed.The pt will undergo normal follow up.
 
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Brand Name
PRESICE CRYOABLATION SYSTEM
Type of Device
CYROSURGICAL UNIT, ACCESSORIES
Manufacturer (Section D)
GALIL MEDICAL LTD.
yokneam
IS 
Manufacturer (Section G)
GALIL MEDICAL LTD
1 tavor building
yokneam 2069 2
IS   20692
Manufacturer Contact
amy mckinney, vice pre
4364 round lake road
arden hills, MN 55112
6512875096
MDR Report Key4307526
MDR Text Key5270481
Report Number9616793-2014-00016
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFPRCH2047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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