MAUDE Adverse Event Report: GALIL MEDICAL ICEROD CX 90 DEGREE NEEDLE/VL; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number FPRPR3533

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.An icerod cx 90 degree needle was selected for use in a cryoablation procedure to treat lung cancer.The first freeze cycle worked without any difficulty.However, during the second freeze cycle, the needle could not reach the desired temperature.An electrical error code occurred.The procedure was then cancelled.There were no patient complications.

Manufacturer Narrative

(b)(6).

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12780562
• MDR Text Key: 280841323
• Report Number: 2134265-2021-13923
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121251
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: U1168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1