MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-29 for EMS SWISS LITHOCLAST LITHOTRIPTER UNK212 manufactured by Boston Scientific - Costa Rica (coyol).
[71200545]
The complainant was unable to provide the upn and device lot number. Therefore, the manufacture and expiration dates are unknown. It was reported the device was not used past its expiry date. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[71200546]
It was reported to boston scientific corporation that a lithoclast ultrasound probe was used for a percutaneous nephrolithotomy procedure on an unknown date. According to the complainant, during the procedure the device caused a perforation in the kidney. There was some bleeding that did not require treatment; however, the procedure was unable to be completed due to this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-00875 |
| MDR Report Key | 6443920 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMS SWISS LITHOCLAST LITHOTRIPTER |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2017-03-29 |
| Model Number | UNK212 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-29 |