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

Model Number	FPRPR3601
Medical Device Problem Codes	Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a needle shaft leak occurred.An icepearl 2.1 cx 90 degree needle was selected for use and during device preparation a shaft leak was noted.A new needle was used and the procedure was completed with no complications reported.
Additional Manufacturer Narrative
H3 - device evaluated by manufacturer: the facility provided media of the actual needle testing which was reviewed.The needle was also returned for engineering analysis and the complaint of a gas leak in the shaft was confirmed.Needle disassembly found solder flux and corrosion were found on the vacuum sleeve.The vacuum sleeve did not lose vacuum.Secondary finding of a gas leak from the needle to handle was seen.A crack in the glue was found in the connection of the needle handle to shaft.
Event or Problem Description
It was reported that a needle shaft leak occurred.An icepearl 2.1 cx 90 degree needle was selected for use and during device preparation a shaft leak was noted.A new needle was used and the procedure was completed with no complications reported.

• 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: 12337401
• Report Number: 2134265-2021-10523
• Device Sequence Number: 4980806
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 06/02/2022
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Patient Age: 60 YR