MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-05-12 for INSTATRAK STRAIGHT ASPIRATOR ENT-100AS-01 manufactured by Visualization Technology, Inc..
[22073448]
The instatrak accuracy was off during surgery by 4-8 mm with one aspirator, 2-4mm. With a second.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225258-1997-00006 |
| MDR Report Key | 91127 |
| Report Source | 05 |
| Date Received | 1997-05-12 |
| Date of Event | 1997-05-07 |
| Date Mfgr Received | 1997-05-07 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-05-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-431-7 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTATRAK STRAIGHT ASPIRATOR |
| Generic Name | ASPIRATOR POINTER |
| Product Code | MGI |
| Date Received | 1997-05-12 |
| Returned To Mfg | 1997-05-09 |
| Model Number | NA |
| Catalog Number | ENT-100AS-01 |
| Lot Number | JAZ6263-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90031 |
| Manufacturer | VISUALIZATION TECHNOLOGY, INC. |
| Manufacturer Address | 30G SIXTH RD. WOBURN MA 01801 US |
| Baseline Brand Name | INSTATRAK STRAIGHT ASPIRATOR |
| Baseline Generic Name | ASPIRATOR/POINTER |
| Baseline Model No | NA |
| Baseline Catalog No | ENT-100AS-01 |
| Baseline ID | ACCESSORY OF IM |
| Baseline Device Family | INSTATRAK ASPIRATING INSTRUMENTS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K960330 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-12 |