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 2016-12-01 for EMS SWISS LITHOCLAST LITHOTRIPTER UNK212 manufactured by Boston Scientific - Costa Rica (coyol).
[61240867]
The exact age of the patient is unknown, however, it was reported the patient was over 18 years. The complainant was unable to report the device upn and lot number; therefore the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[61240868]
It was reported to boston scientific corporation on november 10, 2016 that a lithoclast ultrasound probe was used for a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2016. According to the complainant, during procedure and inside the patient, the probe broke in half and was contained in the scope. Reportedly, the probe heated and the physician burned his right thumb and had a big blister. The procedure was completed another ultrasound probe. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-03722 |
| MDR Report Key | 6138851 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-12-01 |
| 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 | 2016-12-01 |
| 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 | 2016-12-01 |