MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for ULTRASOUND PROBE M0068407170 manufactured by Boston Scientific Corp..
[87206773]
Boston scientific 3. 8 mm x 403 mm ultrasound probe had begun to get hot during the procedure. Upon inspection, it was discovered that the ultrasound probe was broken. The broken device was removed from the field and replaced with a "like" device that was utilized to finish the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072293 |
| MDR Report Key | 6885891 |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-09-20 |
| Date Added to Maude | 2017-09-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRASOUND PROBE |
| Generic Name | ULTRASOUND PROBE |
| Product Code | FFK |
| Date Received | 2017-09-22 |
| Model Number | M0068407170 |
| Catalog Number | M0068407170 |
| Lot Number | 21005651 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |