MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-03-03 for CLASSIC SERIES STABILIZED COLD KNIFE G500 manufactured by Circon Acmi.
[15614898]
Knife blade reportedly broke in pt while cutting a heavy stricture. The broken piece was retrieved, but discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-1999-00014 |
| MDR Report Key | 213568 |
| Report Source | 07 |
| Date Received | 1999-03-03 |
| Date of Report | 1999-03-03 |
| Date of Event | 1999-02-03 |
| Date Added to Maude | 1999-03-12 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC SERIES STABILIZED COLD KNIFE |
| Generic Name | KNIFE |
| Product Code | EZO |
| Date Received | 1999-03-03 |
| Model Number | G500 |
| Catalog Number | G500 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 207200 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | CLASSIC SERIES URETHROTOME COLD KNIFE |
| Baseline Generic Name | URETHROTOME |
| Baseline Model No | G501 |
| Baseline Catalog No | G501 |
| Baseline ID | NA |
| Baseline Device Family | COLD KNIFE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-03 |