MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-21 for TX1 TISSUE REMOVAL SYSTEM - CONSOLE 554-000-000 manufactured by Aol, Inc..
[4272684]
We used 2 separate needles during the case and each time the surgeon stepped on the foot pedal, the acoustic sound took place for a few seconds and then the needle would only shoot out water, we changed the settings on the console numerous times but we still experienced the same problem. The surgeon was very upset and he would like a new console sent to facility immediately. Thank you
Patient Sequence No: 1, Text Type: D, B5
[11813746]
Unit received from the field. This unit was serviced (b)(4) 2012, no malfunction was found, valve spacers were replaced under capa (b)(4), the unit was shipped out (b)(4) 2012. The facility wanted a new console due to recent failures in using the handpiece; the customer was sent unit s/n (b)(4) as replacement; the unit was released to inventory (b)(4) 2012, there are no complaints or service issues on file for this unit; evaluation tx00046 was a refurbish of the unit to return to inventory since it did not go back to the customer; the failure may have been the result of the handpieces and not the console, the microtips were not returned so an investigation cannot be performed; no additional complaints have been filed from this facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085033-2014-00211 |
| MDR Report Key | 3726618 |
| Report Source | 07 |
| Date Received | 2014-01-21 |
| Date of Report | 2014-01-18 |
| Date of Event | 2013-01-22 |
| Date Mfgr Received | 2013-01-22 |
| Device Manufacturer Date | 2012-07-13 |
| Date Added to Maude | 2014-05-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 26902 VISTA TERRACE |
| Manufacturer City | LAKE FOREST CA 92630 |
| Manufacturer Country | US |
| Manufacturer Postal | 92630 |
| Manufacturer Phone | 9494547500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TX1 TISSUE REMOVAL SYSTEM - CONSOLE |
| Generic Name | ULTRASONIC SURGICAL ASPIRATOR MGI |
| Product Code | MGI |
| Date Received | 2014-01-21 |
| Returned To Mfg | 2013-01-28 |
| Catalog Number | 554-000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AOL, INC. |
| Manufacturer Address | LAKE FOREST CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-21 |