MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-02-25 for SONASTAR XS - E SONASTAR XSE GENERA CFSX6 - M240 (MC553) manufactured by Misonix, Inc..
[18597444]
Third time unit used, irrigation pump would not disengage. Thie pump would continue to run regardless of footswitch setting. No adverse effect to patient noted. No procedure delay incurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435119-2005-00006 |
| MDR Report Key | 580538 |
| Report Source | 08 |
| Date Received | 2005-02-25 |
| Date of Report | 2005-02-22 |
| Date of Event | 2004-05-13 |
| Date Mfgr Received | 2004-05-14 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-03-14 |
| 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 | 0 |
| Manufacturer Contact | RONALD MANNA |
| Manufacturer Street | 1938 NEW HIGHWAY |
| Manufacturer City | FARMINGDALE NY 11735 |
| Manufacturer Country | US |
| Manufacturer Postal | 11735 |
| Manufacturer Phone | 6316949555 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONASTAR XS - E |
| Generic Name | ULTRASONIC SURGICAL ASPIRATOR |
| Product Code | LBK |
| Date Received | 2005-02-25 |
| Model Number | SONASTAR XSE GENERA |
| Catalog Number | CFSX6 - M240 (MC553) |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 570386 |
| Manufacturer | MISONIX, INC. |
| Manufacturer Address | 1938 NEW HIGHWAY FARMINGDALE NY 11735 US |
| Baseline Brand Name | SONASTAR XS-E |
| Baseline Generic Name | ULRASONIC SURGICAL ASPIRATOR |
| Baseline Model No | SONASTAR XSE GE |
| Baseline Catalog No | CFSX6-M240 (MC553) |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-25 |