MAUDE Adverse Event Report: GALIL MEDICAL LTD. PRECISE CRYOABLATION SYSTEM; CROSURGICAL UNIT, ACCESSORIES

Model Number FPRC2047

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2013

Event Type  malfunction  

Event Description

A rep called to report an issue during system testing, while the patient was under anesthesia prior to a renal case at cox medical center, springfield, mo.Two needles were inserted in channel one.The channel was locked but the icon that allows the needles to be tested did not appear.The needles were change to channel 2,3, 4 and 5 with the same result.The system was re-booted with same results.Gas pressures were checked and the case had to be cancelled.The rep went back to the facility later in the day and all channels were working properly; the system allowed for all needles to be tested in all channels.

• Brand Name: PRECISE CRYOABLATION SYSTEM
• Type of Device: CROSURGICAL 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, sr director ; 4364 round lake road; arden hills, MN 55112 ; 6512875096
• MDR Report Key: 3983301
• MDR Text Key: 17572167
• Report Number: 9616793-2014-00010
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPRC2047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• 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 Number: 1