MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-30 for LITHOSTAR MODULARIS 05531012 manufactured by Siemens Medical Solutions Usa, Inc..
[18618880]
It was reported by the customer that repeat exams were required on lithostar modularis due to ineffective shock pressure. The customer reviewed the results of the lithotripter treatments going back to (b)(6), 2011, and noticed that 9 out 14 patients had required 2 treatments. This is considered an excessively high retreatment rate since all of the stones were small, the largest measuring 13 mm in diameter. The customer had to follow-up on 12 patients, including 9 patients treated twice, with 10 out of 12 patients having no change in their stones at all. The 7 out of 14 patients have subsequently required either pcnl or ureteroscopy with other being planned. All procedures on the unit were canceled until the issues are resolved.
Patient Sequence No: 1, Text Type: D, B5
[18748068]
Siemens technical support engineer, (b)(4), and clinical applications specialist, (b)(4), were dispatched to this site. On first inspection it was found that there was excessive air in the bellows. The air was removed and pressure test measurements were taken. After the air was removed it was determined that the bellows still contained an air bubble. The source of the air bubble was identified as an air leak. After repair of the leak the shock pressure was checked again and it is now within the specifications called for with the energy level of 4. 5. It was also found that the air bubbles were not clearing when doing a rinse cycle. This was because the hose used to pull the air out of the bellows was positioned incorrectly. After rotating and reseating the bellows to the correct position it was additionally noticed that the coupling pump was running sluggishly. After opening the pump head it was found that the parts were worn and fouled with dirt. The pump head and motor were worn and fouled with dirt. The pump head and motor were replaced. Additionally, the clinical application specialist found that the cross-hair plate that attaches to the image intensifier had been damaged and was loose. This caused the accuracy of the cross-hair to be off by 6-8 mm from the center of the x-ray. The cross-hair plate was replaced with a new one and recalibrated to the center of the image intensifier. The staff at this customer's site was instructed on how to better visualize the air bubbles and how to initiate additional rinse cycles in case there is still air in the bellows. It was also recommended to have one or two key people be trained by applications for setting up the unit before treatments. The applications specialist met with the doctor and his staff and explained what system repairs had been done to resolve the reported issues. The customer agreed with the solution, and the system was cleared for use. The system is functioning at proper specifications. Siemens technical support requested performance maintenance on the system to be done quarterly to better track the issues leading to the reported situations and prevent it from happening in the future. The parts were sent to the factory for further investigation. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2011-00022 |
| MDR Report Key | 2184372 |
| Report Source | 07 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-03-15 |
| Date Mfgr Received | 2011-06-02 |
| Date Added to Maude | 2012-05-15 |
| 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 | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS D-02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTR. 1 |
| Manufacturer City | FORCHHEIM 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOSTAR MODULARIS |
| Generic Name | TABLE, CYSTOMETRIC, ELECTRIC |
| Product Code | MMZ |
| Date Received | 2011-06-30 |
| Model Number | 05531012 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PKWY. MS D-02 MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-30 |