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 2020-02-27 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.
[183174572]
The needle with the reported frost on the shaft formation was returned to the manufacturer for investigation. The needle was tested via a vi system, and passed with all atp and iceball properties within specifications. Frost formation on the needle shaft was not observed during testing. The reported complaint could not be confirmed. The needle lot manufacturing records were reviewed, and no related deviations were recorded within the needle batch.
Patient Sequence No: 1, Text Type: N, H10
[183174573]
During a cryoablation procedure of a desmoid tumour, one of the cryoablation needle's collected frost during the first freeze cycle. The patient's skin was protected with saline and gauze, and the case was completed with no injury to the patient. The defective needle was returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00041 |
| MDR Report Key | 9766492 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR |
| Manufacturer City | WEST CONSHOHOCKEN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| Manufacturer G1 | GALIL MEDICAL LTD. |
| Manufacturer Street | 1 TAVOR BUILDING PO BOX 224, INDUSTRIAL PARK |
| Manufacturer City | YOKNEAM, 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-10 |
| Model Number | FPRPR3602 |
| Catalog Number | FPRPR3602 |
| Lot Number | T0309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GALIL MEDICAL LTD |
| Manufacturer Address | 1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203 IS 2069203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |