MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a needle shaft leak occurred.An icepearl needle was selected for use during a cryoablation procedure.During the needle test phase, bubbles were noted coming from the shaft.The needle was discarded and the procedure continued with another of the same device.No patient involvement.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 12572690
• Report Number: 2134265-2021-12362
• Device Sequence Number: 10980883
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: 04/25/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1