MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-10-08 for KNIGHT NASAL SCISSORS N2886 manufactured by Storz Instrument Company.
[101054]
This tip of this pair of scissors broke off in the pt's nose during surgery. The dr was able to remove the piece with no effect on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00083 |
| MDR Report Key | 125302 |
| Report Source | 06 |
| Date Received | 1997-10-08 |
| Date of Report | 1997-09-08 |
| Date of Event | 1997-09-08 |
| Date Facility Aware | 1997-09-08 |
| Report Date | 1997-09-08 |
| Date Reported to Mfgr | 1997-09-08 |
| Date Mfgr Received | 1997-09-08 |
| Date Added to Maude | 1997-10-10 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KNIGHT NASAL SCISSORS |
| Generic Name | ENT SCISSORS |
| Product Code | KBD |
| Date Received | 1997-10-08 |
| Model Number | NA |
| Catalog Number | N2886 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122661 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 499 SOVEREIGN COURT ST. LOUIS MO 63011 US |
| Baseline Brand Name | KNIGHT NASAL SCISSORS |
| Baseline Generic Name | NASAL SCISSORS |
| Baseline Model No | NA |
| Baseline Catalog No | N2886 |
| Baseline ID | NA |
| Baseline Device Family | GENERAL USE SURGICAL SCISSORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-08 |