MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-07-13 for DORNIER HOLMIUM LASER FIBER HF0200DSSM * manufactured by Dornier Medtech America, Inc..
[754606]
Laser stone extraction - 200 micron laser fiber broke at point of entry into cystoscope, retained fiber removed from the cystoscope. Another 200 micron fiber was used (lot a1504-16s) the same breakage occurred. Rn stated that the acmi company has had problems reported and is stopping production of 200 fiber. No recall on the 200 fibers was sent by the company. No info provided on the event site or contact so follow-up cannot be determined by dornier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2007-00021 |
| MDR Report Key | 975349 |
| Report Source | 00 |
| Date Received | 2007-07-13 |
| Date of Report | 2007-07-05 |
| Date of Event | 2005-01-04 |
| Date Mfgr Received | 2005-01-07 |
| Date Added to Maude | 2008-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THERON GOBER |
| Manufacturer Street | 1155 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146204 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER HOLMIUM LASER FIBER |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-07-13 |
| Model Number | HF0200DSSM |
| Catalog Number | * |
| Lot Number | A1504-16S |
| ID Number | * |
| Device Expiration Date | 2007-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943480 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC. |
| Manufacturer Address | 1155 ROBERTS BLVD. KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-13 |