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 2020-03-10 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.

Event Text Entries

[183175189] Two needles were used in a cryoablation procedure. The patient experienced a muscle stimulation during the procedure. The i-thaw and cautery features could also not be used. The case was completed with no reported injury to the patient. The reported defective needle will be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616793-2020-00058
MDR Report Key9814453
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-10
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-10
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 Received2020-03-10
Returned To Mfg2020-03-04
Model NumberFPRPR3602
Catalog NumberFPRPR3602
Lot NumberA7037
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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 2020-03-10

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