CLOSUREFAST CATHETER Adverse Event — Malfunction (MDR 2183870-2020-00128)
CLOSUREFAST CATHETER Adverse Event — Malfunction (MDR 2183870-2020-00128) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CLOSUREFAST CATHETER; Generic name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES; Manufacturer: COVIDIEN.
| Device | CLOSUREFAST CATHETER |
|---|---|
| Generic name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Manufacturer | COVIDIEN |
| Report number | 2183870-2020-00128 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | PRODUCT ANALYSIS: THE CLOSUREFAST CATHETER WAS RETURNED WITHIN ITS SHELF CARTON AND WITHIN ITS STERILE POUCH. NO ANCILLARY DEVICES, CINE, IMAGES OR PROCEDURE NOTES WERE RETURNED FOR EVALUATION. THE DEVICE WAS REMOVED FROM THE PACKAGING FOR ADDITIONAL ANALYSIS. VISUAL INSPECTION OF THE CATHETER REVEALED NO KINKS OR PHYSICAL DAMAGE. A VISUAL INSPECTION OF THE DEVICE FOUND THE FEP WAS DEFORMED APPROX |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →