MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEFORCE 2.1 CX L 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3618
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced muscle stimulation during active thaw (ithaw).Patient underwent a renal cryoablation procedure with 4 iceforce and 1 iceforce long needles.During the ithaw step of the procedure, the patient told the nurse that the "thing on their back" was causing him to move.The muscle stimulation stopped immediately when the ithaw feature was turned off.The physician continued the case using passive thaw, and the case was successfully completed with no reported patient injury or further complications.The needle causing the muscle stimulation was not identified, as the physician did not want to cause another shock to the patient whilst trying to identify the individual needle causing the problem.
Event or Problem Description
It was reported that the patient experienced muscle stimulation during active thaw (ithaw).Patient underwent a renal cryoablation procedure with 4 iceforce and 1 iceforce long needles.During the ithaw step of the procedure, the patient told the nurse that the "thing on their back" was causing him to move.The muscle stimulation stopped immediately when the ithaw feature was turned off.The physician continued the case using passive thaw, and the case was successfully completed with no reported patient injury or further complications.The needle causing the muscle stimulation was not identified, as the physician did not want to cause another shock to the patient whilst trying to identify the individual needle causing the problem.
Additional Manufacturer Narrative
The needle was not returned to the manufacturer for investigation, and the reported complaint could not be confirmed.Review of the needle lot manufacturing records identified 16 electrical malfunctions within the needle batch.Further internal investigation is being completed to address this issue and reduce the likelihood of such incidents in the future.We will continue to monitor all product complaints for any potential trends related to this issue.
Additional Manufacturer Narrative
Changes made to: e1: initial reporter zip/post code, f10: patient code, f10: impact code, g1: mfr site phone, g1: mfr site fax.Device evaluated by mfr: the device was returned for engineering analysis.A bend in the needle shaft was observed upon physical inspection of the product.However, this had no impact on the functionality of the device.Investigative testing found the needle met all design specifications, including electrical performance.Disassembly of the device revealed the insulation on the heater wire was damaged under spring during the vendor assembly process, resulting in intermittent current leakage from the point of compromise.Patient spasm occurs when current flows through the patient tissue due to poor needle grounding.Further internal investigation is being completed to address this issue and reduce the likelihood of such incidents in the future.
Event or Problem Description
It was reported that the patient experienced muscle stimulation during active thaw (ithaw).Patient underwent a renal cryoablation procedure with 4 iceforce and 1 iceforce long needles.During the ithaw step of the procedure, the patient told the nurse that the "thing on their back" was causing him to move.The muscle stimulation stopped immediately when the ithaw feature was turned off.The physician continued the case using passive thaw, and the case was successfully completed with no reported patient injury or further complications.The needle causing the muscle stimulation was not identified, as the physician did not want to cause another shock to the patient whilst trying to identify the individual needle causing the problem.

• Brand Name: ICEFORCE 2.1 CX L 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10066145
• Report Number: 2134265-2020-06647
• Device Sequence Number: 3775845
• Product Code: GEH
• UDI-Device Identifier: 07290104831089
• UDI-Public: 07290104831089
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2020
• Device Model Number: FPRPR3618
• Device Catalogue Number: FPRPR3618
• Device Lot Number: A1544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2021
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 02/24/2021
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 09/30/2020; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1