RESOLUTION 360 CLIP Adverse Event — Malfunction (MDR 3005099803-2020-01780)
RESOLUTION 360 CLIP Adverse Event — Malfunction (MDR 3005099803-2020-01780) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RESOLUTION 360 CLIP; Generic name: HEMOSTATIC METAL CLIP FOR THE GI TRACT; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | RESOLUTION 360 CLIP |
|---|---|
| Generic name | HEMOSTATIC METAL CLIP FOR THE GI TRACT |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01780 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS |
| Source | openFDA MAUDE (device adverse events) |
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