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

Model Number FPRPR3533

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event is unknown; therefore used manufacturer's aware date.At this time there is no further information available to report.If further relevant information is obtained, a supplemental report will be submitted.

Event Description

It was reported that insufficient freezing occurred.Limited information was reported that two icerod cx 90 needles using a visual-ice system to treat a right renal tumor did not freeze the tumor tissue and did not actively thaw at the end of the procedure.

Manufacturer Narrative

The device was not returned for analysis.Based on the additional information received, it was determined that the event of insufficient ice is most likely related to a temporary needle clog as the remaining needles used in the procedure performed adequately and troubleshooting resolved the problem on one of the two complaint related needles.If insufficient ice formation is observed during the procedure, the needle may be swapped for another, or trouble shooting steps as described in the user manual may resolve a temporary gas clog.The needle ifu advises the user to have an additional needle available and to "continuously monitor the cryoablation procedure using imaging guidance such as direct visualization, ultrasound, computer tomography (ct), or (when using mri-compatible needles only) magnetic resonance (mr)." continuous monitoring allows the physician to detect suboptimal ice formation.The event is unlikely to cause or contribute to a death or serious injury.

Event Description

It was reported that insufficient freezing occurred.Limited information was reported that two icerod cx 90 needles using a visual-ice system to treat a right renal tumor did not freeze the tumor tissue and did not actively thaw at the end of the procedure.It was further reported that eight needles were used in this procedure.Of the two needles reported to not create ice, troubleshooting resolved the issue on the second needle.The case was completed with no patient injury and follow up confirmed that the tumor was well treated.

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam MN 20692 03; IS 2069203
• MDR Report Key: 10718997
• MDR Text Key: 212524213
• Report Number: 2134265-2020-14418
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (y/n): N
• PMA/PMN Number: K121251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: T0286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1