ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-29 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.

Event Text Entries

[182564025] The needle was returned to the manufacturer for investigation. The needle's electrical parameters were found within specification, and the needle was operated several times in thaw mode with no issues. The reported complaint could not be confirmed. The needle lot manufacturing records were reviewed, and 4 electrical malfunctions were recorded within the needle batch.
Patient Sequence No: 1, Text Type: N, H10


[182564026] Two needles were used in a cryoablation procedure. Both needles did not active thaw (ithaw). One of the needles also caused muscle spasms, but the user was unsure which needle caused the spasm. The case was completed with no reported injury to the patient. This mdr is being filed for the second needle used for the cryoablation procedure. Please see mdr # 9616793-2020-00051 for the first needle used in this cryoablation procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616793-2020-00052
MDR Report Key9772616
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-29
Date of Report2020-02-29
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-09-09
Date Added to Maude2020-02-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SANDRA BAUSBACK-ABALLO
Manufacturer Street300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR
Manufacturer CityWEST CONSHOHOCKEN, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1GALIL MEDICAL LTD.
Manufacturer Street1 TAVOR BUILDING PO BOX 224, INDUSTRIAL PARK
Manufacturer CityYOKNEAM, 2069203
Manufacturer CountryIS
Manufacturer Postal Code2069203
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE
Generic NameCRYOABLATION NEEDLE
Product CodeGEH
Date Received2020-02-29
Returned To Mfg2020-02-17
Model NumberFPRPR3602
Catalog NumberFPRPR3602
Lot NumberT0120
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGALIL MEDICAL LTD
Manufacturer Address1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203 IS 2069203


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-29

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