MAUDE Adverse Event Report: BTG YOKNEAM ICEROD 90 DEGREE MRI NEEDLE / MRI; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3195
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a needle air leak occurred.An icerod 90 degree mri needle was selected for the index cryoablation procedure.During preparation, however, there was an air leak observed.The procedure was completed using a different device of the same model.There were no patient complications reported.

• Brand Name: ICEROD 90 DEGREE MRI NEEDLE / MRI
• 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 ISRAEL; tavor bldg 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15203975
• Report Number: 2134265-2022-08449
• Device Sequence Number: 2067832
• Product Code: GEH
• UDI-Device Identifier: 07290104830297
• UDI-Public: 07290104830297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 12/02/2024
• Device Model Number: FPRPR3195
• Device Catalogue Number: FPRPR3195
• Device Lot Number: U4135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown