MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEROD PLUS 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3508
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cryoablation needle formed frost during the second freeze cycle of the cryoablation procedure.Frostbite was observed near the cryoablation needle entry site of the patient's skin.The patient was treated for frostbite, but the injury was not serious in nature and did not require intervention to prevent serious injury or impairment.Frost formation was not observed during testing of the cryoablation needle.The user attempted to irrigate the skin around the insertion site with saline, but the irrigation was as not as effective as observed in prior experience with previous models of the cryoablation needle.The needle with the reported frost formation was not used in the third freeze cycle of the cryoablation procedure.The case was completed with no further reported injury to the patient.
Additional Manufacturer Narrative
The device was returned for engineering analysis and the complaint was confirmed for 'frost on shaft'.The shaft temperature of -13.9 c points to insufficient thermal insulation of the needle.The ice ball size was within the specification was not compromised due to thermal insulation loss.The needle was disassembled and soldering flux residuals and corrosive signs were seen on the vacuum sleeve external surfaces.These observations did not lead to the vacuum loss reported because there were no corrosive holes in the sleeve.The device was also tested for leaks and no gas leaks were detected.Review of the needle lot manufacturing records did not identify any related vacuum sleeve malfunctions within the needle batch.
Event or Problem Description
It was reported that a cryoablation needle formed frost during the second freeze cycle of the cryoablation procedure.Frostbite was observed near the cryoablation needle entry site of the patient's skin.The patient was treated for frostbite, but the injury was not serious in nature and did not require intervention to prevent serious injury or impairment.Frost formation was not observed during testing of the cryoablation needle.The user attempted to irrigate the skin around the insertion site with saline, but the irrigation was as not as effective as observed in prior experience with previous models of the cryoablation needle.The needle with the reported frost formation was not used in the third freeze cycle of the cryoablation procedure.The case was completed with no further reported injury to the patient.

• Brand Name: ICEROD PLUS 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bld 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10454168
• Report Number: 2134265-2020-11709
• Device Sequence Number: 3524206
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 10/31/2021
• Device Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: T0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1