MAUDE Adverse Event Report: BTF Yokneam Iceforce 2.1 CX 90 Degree Needle; Unit, Cryosurgical, Accessories

Model Number	FPRPR3602
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• Brand Name: Iceforce 2.1 CX 90 Degree Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTF Yokneam; tavor building 1; industrial park; yokneam, ; IS
• Manufacturer (Section G): Galil Medical Ltd.; industrial park; tavor building 1; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50495387
• Report Number: 2124215-2026-45857
• Device Sequence Number: 10630577
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: (01)07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown