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 2018-01-16 for 3.3 MM X 403 MM ULTRASOUND PROBE M0068407160 840-716 manufactured by Boston Scientific - Spencer.
[97326027]
Mfg site name- (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
[97326028]
It was reported to boston scientific corporation on (b)(6) 2017 that an ultrasound probe was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017. According to the complainant, during the procedure, the ultrasound probe broke about 4cm from the proximal end. Half of the broken piece fell inside the patient and was retrieved with the use of forceps. The procedure was completed with a different device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00093 |
| MDR Report Key | 7193258 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2018-01-16 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.3 MM X 403 MM ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2018-01-16 |
| Model Number | M0068407160 |
| Catalog Number | 840-716 |
| Lot Number | 21380570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-16 |