MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-19 for LITHOSTAR MODULARIS 01159107 manufactured by Siemens Ag.
[2834055]
It was reported that on (b)(6) 2012, two patients were treated on a mobile lithostar modularis unit at two different facilities by different operating technicians. The first patient, a (b)(6) female, was treated at 9 am for a stone in her right distal uterus. This patient received 4,000 shocks, at 60 shocks per minute, at maximum power level 6. The procedure lasted for almost an hour and half but approximately 1 cm stone did not appear to change. Three days after the procedure the patient was diagnosed with a ruptured spleen. The spleen had to be removed. The second patient was treated for a stone in the left uterero-pelvic junction. The patient was injected with contrast and a stent was placed. The patient received 3500 shocks, at 60 shocks per minute, at maximum power level 3. 2. After the procedure the patient developed a left subcapsular hematoma. The patient received blood transfusion several days later.
Patient Sequence No: 1, Text Type: D, B5
[10048256]
Siemens local service engineer, (b)(4), checked the system. The engineer performed a pressure test on the shock head and it was within tolerance. No causal relationship between the events and the device could be found. Over 3000 patients were treated on this system without any reported incidents. The customer stated that the injuries were not related to the system function and continues to use the unit. The reported issues have not reoccurred. The investigation is on-going.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2012-05937 |
| MDR Report Key | 2661681 |
| Report Source | 07 |
| Date Received | 2012-07-19 |
| Date of Report | 2012-07-19 |
| Date of Event | 2012-06-11 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-07-19 |
| 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 | SERVICE PERSONNEL |
| 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 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM, GERMANY 91301 |
| Manufacturer Postal Code | 91301 |
| 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 | 2012-07-19 |
| 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 | SIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-19 |