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 2019-02-05 for ULTRASOUND PROBE M0068407170 840-717 manufactured by Boston Scientific Corporation.
[135034990]
The reported lot number 08714729516613 does not match with the reported upn. Therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device 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
[135034991]
It was reported to boston scientific corporation on (b)(6) 2019 that a lithoclast ultrasound probe was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, an ultrasound probe was used and it overheated and broke in half. Reportedly, there were no broken fragments that fell inside the patient and the patient was not burned due to overheating. The procedure was successfully completed using another lithoclast ultrasound probe. There was no serious injury or adverse effect to the patient as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00397 |
| MDR Report Key | 8306005 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-02-05 |
| 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 | 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 VUARPILLI 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 | 2019-02-05 |
| Model Number | M0068407170 |
| Catalog Number | 840-717 |
| 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 | 2019-02-05 |