MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEFORCE¿ 2.1 CX L 90° NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3618
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle Spasm(s) (1966)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Two needles were used during a cryoablation case.This mdr is being submitted for the first of the needles used during the cryoablation procedure.During the active thaw cycle towards the end of the procedure, one of the two needles caused muscle stimulation.The case was completed, with no reported injury to patient.The user is unsure which of the needles caused the muscle stimulation.The needles will be returned to the manufacturer for investigation.
Additional Manufacturer Narrative
The needle was returned to the manufacturer for investigation.The electrical properties of the needle was found to be within specifications, and the needle operated successfully in ithaw mode with no issues.The reported complaint could not be confirmed.The needle lot manufacturing records were reviewed, and no electrical malfunctions were recorded within the needle batch.
Event or Problem Description
This follow up mdr is to document the findings of the manufacturer's investigation of needle 1 used in this complaint.Please see mdr # 9616793-2020-00017 for needle 2 used in this case.No further follow up or investigation is anticipated for this needle.

• Brand Name: ICEFORCE¿ 2.1 CX L 90° NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03,; IS 2069203,
• MDR Report Key: 9703425
• Report Number: 9616793-2020-00016
• Device Sequence Number: 1708939
• Product Code: GEH
• UDI-Device Identifier: 07290104831089
• UDI-Public: 07290104831089
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2020

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: 09/09/2021
• Device Model Number: FPRPR3618
• Device Catalogue Number: FPRPR3618
• Device Lot Number: T0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1