MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-18 for LUMENIS SLIMLINE 200 FOR COHERENT 200 * manufactured by Lumenis, Inc..
[16361516]
Pt admitted for nephrolithiasis. In 2003, pt underwent a right ureteroscopy, cystoscopy and laser lithotripsy. During the procedure, pt was found to have an impacted, dense, hard stone. A fragment of the fiber broke off and moved forward (2. 5cm 200 holmium) and despite multiple attempts, retrieval was unsuccessful and the fiber tip was retained. Pt subsequently was diagnosed with a retroperitoneal bleed and expired later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 622094 |
| MDR Report Key | 622094 |
| Date Received | 2005-07-18 |
| Date of Report | 2005-07-15 |
| Date of Event | 2003-10-02 |
| Date Facility Aware | 2003-10-02 |
| Report Date | 2005-07-15 |
| Date Reported to FDA | 2005-07-15 |
| Date Reported to Mfgr | 2005-07-15 |
| Date Added to Maude | 2005-07-22 |
| 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 | 3 |
| 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 SLIMLINE 200 FOR COHERENT 200 |
| Generic Name | FIBER DELIVERY DEVICE |
| Product Code | MVF |
| Date Received | 2005-07-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 072601 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611740 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 2400 CONDENSA ST SANTA CLARA CA 95051 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Other; 4. Required No Informationntervention | 2005-07-18 |