MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-26 for CIRCON ACMI RAC-B * manufactured by Ciron Acmi.
[15745886]
During a surgical procedure a cautery accessory cable closest to the resectoscope began to spark near the physician's face. The cable was discontinued from use immediately. It was noted that the connector end frayed and broke. There was no flame or fire on drapes nor injury to patient, staff or physician. The esu unit was also inspected and was operating correctly. Found that the ground on the power plug of the esu was intermittently bad when twisted and so the power cord was replaced. This, however, had no effect on accessory cable sparking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022270 |
| MDR Report Key | 339630 |
| Date Received | 2001-06-26 |
| Date of Report | 2001-06-18 |
| Date of Event | 2001-06-12 |
| Date Added to Maude | 2001-07-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CIRCON ACMI |
| Generic Name | CABLE, CAUTERY ACCESSORY |
| Product Code | FFZ |
| Date Received | 2001-06-26 |
| Model Number | RAC-B |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 328954 |
| Manufacturer | CIRON ACMI |
| Manufacturer Address | 200 STILLWATER AVENUE STAMFORD CT 069023695 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-26 |