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.
[183174293]
The defective needle was not returned to the manufacturer, and the reported complaint could not be confirmed. The needle lot manufacturing records were reviewed, and no electrical deviations were found within the needle batch.
Patient Sequence No: 1, Text Type: N, H10
[183174394]
Three iceforce needles were used in a cryoablation procedure. During the treatment, one needle caused skin discolouration. After the treatment was completed, the user noticed a skin burn near the needle insertion site. The burn team reviewed and treated the burn, and the patient was sent home. Muscle stimulation was also observed during the procedure with a separate needle used in this procedure. Please see mdr # 9616793-2020-00039 for the report that describes this event. The defective needle was discarded, and therefore cannot be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00040 |
| MDR Report Key | 9766461 |
| 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 | 2019-11-03 |
| 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 |
| Model Number | FPRPR3602 |
| Catalog Number | FPRPR3602 |
| Lot Number | T0344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-02-27 |