MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-07-24 for STORZ NEIVERT-EVE TONSIL SNARE N6370 manufactured by Storz Instrument Co..
[7763087]
The sales representative vistied the account and indicated that unfamiliarity with this product was most probalby the cause for the problems experienced. This account was used to using another type of snare. The representative explained how this tonsil snare works and made some suggestions to them on wire usage that should solve their problems. This tonsil snare is working properly; there are no defects with the snare.
Patient Sequence No: 1, Text Type: N, H10
[17258552]
During a tonsillectomy procedure, the doctor put the snare on the tonsil the snare wire got stuck. The tonsil had to be cut out around the snare wire so that it could be removed. The pt did not suffer any adverse effects as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00063 |
| MDR Report Key | 108630 |
| Report Source | 05,06 |
| Date Received | 1997-07-24 |
| Date of Report | 1997-06-26 |
| Date of Event | 1997-06-26 |
| Date Facility Aware | 1997-06-26 |
| Report Date | 1997-06-26 |
| Date Reported to Mfgr | 1997-06-26 |
| Date Mfgr Received | 1997-06-26 |
| Date Added to Maude | 1997-07-30 |
| 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 | STORZ NEIVERT-EVE TONSIL SNARE |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 1997-07-24 |
| Model Number | NA |
| Catalog Number | N6370 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106764 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT. ST LOUIS MO 63011 US |
| Baseline Brand Name | NEIVERT-EVE TONSIL SNARE |
| Baseline Generic Name | TONSIL SNARE |
| Baseline Model No | NA |
| Baseline Catalog No | N6370 |
| Baseline ID | NA |
| Baseline Device Family | TONSIL SNARE |
| 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 | 1. Required No Informationntervention | 1997-07-24 |