MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-02-03 for SONASTAR XS-CURVED EXTENDED HANDPIECE SONASTAR XSE CE CFSX6-H212 (MC585) manufactured by Misonix, Inc..
[345943]
Used during craniectomy for tumor, irrigation will not shut off after two minutes as described to customer. Irrigation was running continuously for approximately 1 hour but was not utilized during procedure, at that point (400 cc of fluid). Suction was on zero, however, it was suctioning. Surgeon states that it was too much. Plugged in coagulation and bovie, turned it on, unit continually ran. Unable to turn it off. They must unplug from wall. No alarms on device and ultrasonics were noted as running fine. At the time of the call the patient had not suffered any adverse effects as a result of the incident. Surgery was prolonged approximately 1 hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435119-2005-00003 |
| MDR Report Key | 574603 |
| Report Source | 08 |
| Date Received | 2005-02-03 |
| Date of Report | 2005-01-31 |
| Date of Event | 2004-10-07 |
| Date Mfgr Received | 2004-10-11 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-02-23 |
| 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 | MISONIX INC. |
| Manufacturer Street | 1938 NEW HIGHWAY |
| Manufacturer City | FARMINGDALE NY 11735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | C002 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONASTAR XS-CURVED EXTENDED HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL ASPIRATOR HANDPIECE |
| Product Code | FLF |
| Date Received | 2005-02-03 |
| Model Number | SONASTAR XSE CE |
| Catalog Number | CFSX6-H212 (MC585) |
| 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 | 564451 |
| Manufacturer | MISONIX, INC. |
| Manufacturer Address | * FARMINGDALE NY * US |
| Baseline Brand Name | SONASTAR XSE CURVED EXTENDED HANDPIECE |
| Baseline Generic Name | ULTRASONIC SURGICAL ASPIRATOR HANDPIECE |
| Baseline Model No | SONASTAR XSE CE |
| Baseline Catalog No | CFSX6-S212 |
| Baseline ID | MC 585 |
| Baseline Device Family | SONASTAR ULTRASONIC SURGICAL SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K032690 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-03 |