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 2019-04-24 for ULTRASOUND PROBE M0068407170 840-717 manufactured by Boston Scientific Corporation.
[142934767]
User facility/medwatch number: (b)(4). (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[142934768]
It was reported to boston scientific corporation that a lithoclast ultrasound probe was used during a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2019. According to the complainant, during the procedure, the ultrasound probe broke in half midway through the procedure and the broken piece was removed from the sterile field. The procedure was completed with another lithoclast ultrasound probe. There were no serious injury/adverse effect to patient as a result of the event. Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02179 |
| MDR Report Key | 8545266 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-04-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | ELECTRO MEDICAL SYSTEMS SA |
| Manufacturer Street | CH. DE LA VUARPILLIERE 31 CH-1260 |
| Manufacturer City | NYON, SZ 1260 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2019-04-24 |
| Model Number | M0068407170 |
| Catalog Number | 840-717 |
| Lot Number | 0023023809 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |