MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for CAPIO DEVICE M005 manufactured by Boston Scientific Corp..
[182895146]
Capio device malfunctioned. Suspected " metal arrow" (suture) stuck in device (misfire). New device opened and functioned without trouble.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093584 |
| MDR Report Key | 9800782 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-04 |
| Date Added to Maude | 2020-03-06 |
| 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 | UNKNOWN |
| 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 | CAPIO DEVICE |
| Generic Name | INSTRUMENT, SURGICAL MESH, UROGYNECOLOGIC |
| Product Code | PWI |
| Date Received | 2020-03-05 |
| Catalog Number | M005 |
| Lot Number | 23495814 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |