MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-10 for DUO TOME SIDELITE 550 840-846 manufactured by Lumenis.
[745668]
During operation of the holmium laser during a surgical case, the single use 550 duo tome fiber burned through its fiber and insulation causing a burn to the surgeon's palm. The event occurred approx 20 mins after the laser/fiber delivery system were in use. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004946 |
| MDR Report Key | 978337 |
| Date Received | 2008-01-10 |
| Date of Event | 2008-01-02 |
| Date Added to Maude | 2008-01-18 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUO TOME SIDELITE 550 |
| Generic Name | FIBER DELIVERY DEVICE |
| Product Code | LNK |
| Date Received | 2008-01-10 |
| Catalog Number | 840-846 |
| Lot Number | 62320807 |
| Device Expiration Date | 2012-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948517 |
| Manufacturer | LUMENIS |
| Manufacturer Address | 5302 BETSY ROSS DR SANTA CLARA CA 95054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-10 |