MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-12-11 for LITHOSTAR MODULARIS 05531103 NA manufactured by Siemens Medical Solutions Usa, Inc..
[15217178]
It was reported that immediately following a lithotripsy procedure, a male patient developed a perforated bowel which required surgical correction (small bowel resection), performed by md. The lithotripsy treatment was for a 7x8 mm stone in the right mid-ureter. Service checked the unit, and no causal relationship between the event and the device could be found.
Patient Sequence No: 1, Text Type: D, B5
[15656099]
According to the customer, approximately 75 patients were treated since the event, with no noticable problems encountered. The patient's stone was previously treated in 2009, at the right upj with 4000 shocks at 4. 0 power level, 3. 4 power level average with total energy of 185. 25 with poor results. Because of this and other poor results, steps were initiated to determine the effectiveness of the shock head. The shock head was replaced just prior to the patient's second treatment the following month.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2009-00040 |
| MDR Report Key | 1558371 |
| Report Source | 07 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-12-08 |
| Date of Event | 2009-10-05 |
| Date Mfgr Received | 2009-11-06 |
| Date Added to Maude | 2009-12-16 |
| 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 | JOSEPH ALESSI |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104481765 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | 127 HENKESTRASSE |
| Manufacturer City | ERLANGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| 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 | 2009-12-11 |
| Model Number | 05531103 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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. MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-12-11 |