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 TXI TISSUE REMOVAL SYSTEM - MICROTIP 554-1003-001 manufactured by American Optisurgical, Inc..
[4437018]
Product was working and in the middle of the case it quit emitting ultrasound.
Patient Sequence No: 1, Text Type: D, B5
[11875670]
There is no service record, and without evaluating the unit, the cause for malfunction cannot be determined. It is believed that a burr on the compression nut resulted in the failure. The burr call-out is on the drawing. Engineering updated the drawing to ensure technicians make the proper assessment. An engineering change order was generated to cover implementation of applicable dwgs. This lot has a (b)(4) complaint rate. The high number of complaints would be expected due to the burrs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085033-2013-00002 |
| MDR Report Key | 3769193 |
| Report Source | 07 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-29 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-03-08 |
| Device Manufacturer Date | 2012-02-15 |
| 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 | TXI TISSUE REMOVAL SYSTEM - MICROTIP |
| Generic Name | ULTRASOUND SURGICAL ASPIRATORY MGI |
| Product Code | MGI |
| Date Received | 2013-12-30 |
| Catalog Number | 554-1003-001 |
| Lot Number | 00312-07 |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |