MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-02 for LUMENIS DUOTOME SIDELITE 550 840-846 * manufactured by Lumenis, Inc..
[767647]
During a laser ablation of the prostate the machine malfunctioned, the circulator saw a 'flash' and the machine shut down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 953392 |
| MDR Report Key | 953392 |
| Date Received | 2007-11-02 |
| Date of Report | 2007-11-02 |
| Date of Event | 2007-10-17 |
| Report Date | 2007-11-02 |
| Date Reported to FDA | 2007-11-02 |
| Date Added to Maude | 2007-11-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | LUMENIS DUOTOME SIDELITE 550 |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-11-02 |
| Model Number | 840-846 |
| Catalog Number | * |
| Lot Number | 58190607 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 924144 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 2400 CONDENSA STREET SANTA CLARA CA 950510901 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-02 |