MAUDE Adverse Event Report: GALIL MEDICAL LTD. SEEDNET GOLD CRYOABLATION SYSTEM; CRYOSURGICAL UNIT, ACCESSORIES

Model Number FPRCH2024

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/24/2013

Event Type  malfunction  

Event Description

During a cryoablation treatment, the needles stopped freezing after 40 seconds of freezing (first cycle) on groups 1 and 2.The user called the local fse and he recommended to put the needles on group 3.When testing the needles on group 3, the needles did not stop freezing after the end of the freezing cycle of the test phase, which suggests that the solenoid on this group was gripped.The physician decided to cancel the treatment and postpone it.

• Brand Name: SEEDNET GOLD CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; yokneam ; IS
• Manufacturer (Section G): GALIL MEDICAL LTD.; 1 tavor bldg; yokneam 2069 2; IS 20692
• Manufacturer Contact: amy mckinney, director ; 4364 round lake rd; arden hills, MN 55112 ; 6512875096
• MDR Report Key: 3647202
• MDR Text Key: 4201231
• Report Number: 9616793-2014-00001
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPRCH2024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2013
• 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