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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES
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GALIL MEDICAL LTD. ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES Back to Search Results
Model Number FPRPR3573
Medical Device Problem Code Thermal Decomposition of Device (1071)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/22/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that frost on the shaft was observed.During a lung cryoablation procedure using two icesphere 1.5 cx 90 degree needles, frost was observed on the entire shaft of one of the needles and was adhered to the patient's skin.The treatment was completed successfully using both original devices with no injury to the patient.
 
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Brand Name
ICESPHERE 1.5 CX 90 DEGREE
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 Key12169697
Report Number2134265-2021-08897
Device Sequence Number17288361
Product Code GEH
UDI-Device Identifier07290104831133
UDI-Public07290104831133
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/14/2021
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 Date10/24/2022
Device Model NumberFPRPR3573
Device Catalogue NumberFPRPR3573
Device Lot NumberU1461
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/05/2021
Initial Report FDA Received Date07/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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