MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for LOTTA VENTRICULOSCOPE 28164LA manufactured by Karl Storz Se & Co. Kg.
[107562208]
On february 16, 2018, we were contacted by an attorney's office representing a patient that underwent an endoscopic craniotomy procedure at (b)(6) on (b)(6) 2015. During the procedure there was a significant, serious complication, and the patient was left with brain damage. We were informed that they plan to depose our sales repsentative, who allegedly was present during the procedure. It is not clear to us which instrument was involved. We are, therefore, using the telescope as the representative instrument in this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00034 |
| MDR Report Key | 7492763 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-02-16 |
| Date of Event | 2015-02-09 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-05-07 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOTTA VENTRICULOSCOPE |
| Generic Name | NEUROENDOSCOPE |
| Product Code | GWG |
| Date Received | 2018-05-07 |
| Model Number | 28164LA |
| Catalog Number | 28164LA |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-07 |