MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-05 for DAC CAUTERY CORD (AE) DISPOSABLE ITEM * manufactured by Circon Acmi.
[109930]
Tech observed flash of light at connection between cautery cord and resectoscope, then smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013932 |
| MDR Report Key | 171614 |
| Date Received | 1998-06-05 |
| Date of Report | 1998-06-05 |
| Date of Event | 1998-06-01 |
| Date Added to Maude | 1998-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAC CAUTERY CORD (AE) DISPOSABLE ITEM |
| Generic Name | * |
| Product Code | FFZ |
| Date Received | 1998-06-05 |
| Model Number | AE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 166897 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 300 STILLWATER AVE. STAMFORD CT 069041971 US |
| Baseline Brand Name | DISPOSABLE ACTIVE CORD |
| Baseline Generic Name | ACTIVE CORD |
| Baseline Model No | DAC |
| Baseline Catalog No | DAC |
| Baseline ID | NA |
| Baseline Device Family | ACTIVE CORD |
| 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 | 1998-06-05 |