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

Model Number	FPRPR3508
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost occurred on all parts of the needle.An icerod plus 90 degree needle was selected for a rectal cancer cryoablation procedure.During the procedure, it was observed that frost occurred on all parts of the needle and the freezing range of the cryoablation needle exceeded the intended range.A mild trace of skin hypothermia was reported, and the skin was protected with a warm water bag.The needle was exchanged and the procedure was completed.There were no patient consequences as a result of this event.

• Brand Name: Icerod Plus 90 Degree Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG Yokneam; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): Boston Scientific Corporation; tavor building number 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: 50938700
• Report Number: 2124215-2026-51805
• Device Sequence Number: 21265880
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: (01)07290104830563(17)271228(10)38251430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: 0038251430
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 12/28/2025
• 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: 74 YR
• Patient Sex: Male