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

Model Number FPRCH2024

Device Problems Computer Operating System Problem (2898); Mechanics Altered (2984)

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

Event Date 02/04/2016

Event Type  malfunction  

Event Description

Prior to a prostate cryoablation procedure, during system start up the computer locked up while trying to scan the scan card numbers.The user rebooted the system, switched keyboard and tried to enter the numbers manually; nothing worked.The user switched to another company's system complete the case.The patient was under anesthesia during system startup at the doctors request.

Manufacturer Narrative

A galil medical field service engineer visited the system for a service call.Power was applied to the system and the keyboard did not respond, confirming the customer complaint.After replacing the keyboard, the system booted up and performed all functions as expected.The keyboard was replaced and the system was left in proper working order.

• Brand Name: SEEDNET GOLD CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL SYSTEM AND ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: amy mckinney ; 1 tavor building, po box 224; industrial park; yokneam, 20692 ; IS 20692 ; 2875096
• MDR Report Key: 5477102
• MDR Text Key: 40029289
• Report Number: 9616793-2016-00005
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: FPRCH2024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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