MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for SENSATION SHORT THROW POLYPECTOMY SNARE M00562670 manufactured by Boston Scientific Corporation.
[183875697]
Polypectomy snare malfunctioned upon initial deployment for a recto-sigmoid colon polyp, requiring removal of device and opening and inserting a new polypectomy snare. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093762 |
| MDR Report Key | 9834862 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-10 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | SENSATION SHORT THROW POLYPECTOMY SNARE |
| Generic Name | SNARE, FLEXIBLE |
| Product Code | FDI |
| Date Received | 2020-03-13 |
| Model Number | M00562670 |
| Lot Number | 24850953 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |