MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-24 for GERACI/MILLER SMOKE EVACUATION SE11111 B11 * manufactured by Lase, Inc..
[31036]
Pt having egd when laser smoke evacuator failed. Procedure terminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 47669 |
| MDR Report Key | 47669 |
| Date Received | 1996-10-24 |
| Date of Report | 1996-10-24 |
| Date of Event | 1996-10-18 |
| Date Facility Aware | 1996-10-18 |
| Report Date | 1996-10-24 |
| Date Added to Maude | 1996-11-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GERACI/MILLER SMOKE EVACUATION |
| Generic Name | LASER SMOKE EVACUATOR |
| Product Code | FCZ |
| Date Received | 1996-10-24 |
| Model Number | SE11111 B11 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 48457 |
| Manufacturer | LASE, INC. |
| Manufacturer Address | PO BOX 36158 CINCINNATI OH 45236 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-24 |