MAUDE Adverse Event Report: BTG YOKNEAM ICEROD NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3203
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was frost along the length of the needle shaft.Icerod needles were selected for a cryoablation procedure in the liver.During the procedure, about 1-3 minutes into the freeze, frost formed on the shafts of all the needles.A glove filled with hot water was used to protect the skin from freezing.The procedure was continued with the original needles.There were no patient complications reported.
Additional Manufacturer Narrative
D4: lot number and expiration date updated.
Event or Problem Description
It was reported that there was frost along the length of the needle shaft.Icerod needles were selected for a cryoablation procedure in the liver.During the procedure, about 1-3 minutes into the freeze, frost formed on the shafts of all the needles.A glove filled with hot water was used to protect the skin from freezing.The procedure was continued with the original needles.There were no patient complications reported.

• Brand Name: ICEROD NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; tavor building 1; industrial park; yokneam ; IS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20631500
• Report Number: 2124215-2024-69891
• Device Sequence Number: 8038996
• Product Code: GEH
• UDI-Device Identifier: 07290104830198
• UDI-Public: 07290104830198
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 12/30/2024
• Device Model Number: FPRPR3203
• Device Catalogue Number: FPRPR3203
• Device Lot Number: U4358
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/14/2024
• Date Device Manufactured: 01/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown