MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-30 for TX1 TISSUE REMOVAL SYSTEM - MICROTIP 554-1003-001 manufactured by American Optisurgical, Inc..
[15105678]
Two failed hps.
Patient Sequence No: 1, Text Type: D, B5
[15337080]
During the evaluation, the technician found that one of the handpieces would not prime. Upon closer inspection, we found that fluid was leaking from the protective cap and nose cone joint. The protective cap was not installed properly. We were unable to determine whether this was an error in assembly or if the customer had tampered with the cap before the priming cycle. The second handpiece functioned within all specifications. The handpiece primed and worked properly at all three cutting power levels.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085033-2013-00004 |
| MDR Report Key | 3769178 |
| Report Source | 07 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-29 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-02-22 |
| Device Manufacturer Date | 2012-01-26 |
| Date Added to Maude | 2014-05-13 |
| 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 - MICROTIP |
| Generic Name | ULTRASONIC SURGICAL ASPIRATOR MGI |
| Product Code | MGI |
| Date Received | 2013-12-30 |
| Returned To Mfg | 2012-02-22 |
| Catalog Number | 554-1003-001 |
| Lot Number | 00912-01 |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN OPTISURGICAL, INC. |
| Manufacturer Address | LAKE FOREST CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-30 |