MAUDE Adverse Event Report: BTG YOKNEAM ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a needle frost occurred.An icepearl 2.1 cx 90 degree needle was selected for treatment of a renal cell carcinoma in the patient.The needle passed testing and was inserted into the patient.When the stick option was initiated the shaft began to freeze and ice went down the needle shaft.The needle was warmed and removed.The procedure was completed with another needle.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval.By manufacturer: the device was returned for engineering analysis and the complaint was confirmed.Testing confirmed shaft temperature points to insufficient thermal insulation of the needle.The complete shaft was covered in frost therefore the atp system could not recognize the ice ball margins.No leak was found on the vacuum sleeve external surface during the vacuum sleeve bubble test.Secondary findings of soldering flux and tin residuals were found on the vacuum sleeve external surface.
Event or Problem Description
It was reported that a needle frost occurred.An icepearl 2.1 cx 90 degree needle was selected for treatment of a renal cell carcinoma in the patient.The needle passed testing and was inserted into the patient.When the stick option was initiated the shaft began to freeze and ice went down the needle shaft.The needle was warmed and removed.The procedure was completed with another needle.There were no patient complications reported.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE 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 ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13011322
• Report Number: 2134265-2021-15417
• Device Sequence Number: 13884827
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 02/27/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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