BIORAPTOR 2.9 WITH ULTRABRAID Adverse Event — Malfunction (MDR 1219602-2008-00031)
BIORAPTOR 2.9 WITH ULTRABRAID Adverse Event — Malfunction (MDR 1219602-2008-00031) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BIORAPTOR 2.9 WITH ULTRABRAID; Generic name: BIORAPTOR; Manufacturer: SMITH & NEPHEW INC., ENDOSCOPY DIV..
| Device | BIORAPTOR 2.9 WITH ULTRABRAID |
|---|---|
| Generic name | BIORAPTOR |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Report number | 1219602-2008-00031 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | User facility, Company representation |
| Narrative | AFTER INSERTION OF THE BIORAPTOR KNOT WAS TIED. AS THE SURGEON WAS PROBING THE FIXATION, HE NOTICED THAT THE SECOND/MIDDLE ANCHOR HAD BROKEN AT THE EYELET. THE ANCHOR WAS LEFT IN PLACE. THE SURGEON DID NOT PLACE ANY ADDITIONAL ANCHORS AS HE FELT ADEQUATE FIXATION WAS ACHIEVED. |
| Source | openFDA MAUDE (device adverse events) |
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