MAUDE Adverse Event Report: BTG Yokneam Icerod CX 90 Degree Needle/VL; Unit, Cryosurgical, Accessories

Model Number	FPRPR3533
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft frost occurred.An icerod cx 90 degree needle/vl was selected for use.During the first freeze, the needle frosted up the shaft, and an audible high-pitched noise was noted.The needle was exchanged and the procedure was completed.There were no patient consequences as a result of this event.

• Brand Name: Icerod CX 90 Degree Needle/VL
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG Yokneam; tavor building 1, industrial p; po box 224; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): Boston Scientific Corporation; tavor building number 1, yokne; 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: 50569603
• Report Number: 2124215-2026-46373
• Device Sequence Number: 13382717
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121251
• 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): 09/02/2026

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: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0037067180
• 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: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 07/28/2025
• 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 Age: 63 YR
• Patient Sex: Female