MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-10 for LITHOSTAR MODULARIS 01159107 manufactured by Siemens Ag.
[2984599]
Siemens was informed that three to four patients who were treated on the lithostar modularis system developed hematoma of the kidney after eswl treatments. The patients were treated by different operators on the unit in (b)(6) 2012. According to siemens local service, the patients were hospitalized after treatments. Information regarding their treatments or conditions was not provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[10333977]
The systems was checked by siemens local service engineer, (b)(6). The unit was found to be within specifications. Selection of adequate therapy parameters is the responsibility of the operator, and is dependent on the patient's condition and state of health. Contradictions and energy levels are described in the operator manual for lithostar modularis system (b)(4). Medical publications state that kidney hematoma is a possible adverse effect of eswl therapy. It is not system specific, but is eswl application specific.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2012-10484 |
| MDR Report Key | 2862597 |
| Report Source | 07 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-09 |
| Date of Event | 2012-11-09 |
| Date Mfgr Received | 2012-11-09 |
| Date Added to Maude | 2012-12-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY MS D-02 |
| Manufacturer City | MALVERN PA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOSTAR MODULARIS |
| Generic Name | UROLOGICAL TABLE AND ACCESSORIES |
| Product Code | MMZ |
| Date Received | 2012-12-10 |
| Model Number | 01159107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-12-10 |