MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-02 for 23 GAUGE ONE STEP VALVED CANNULA 58.23V manufactured by Synergetics.
[17976301]
Surgeon performing a vitrectomy using synergetics valved cannula, 58. 23v, and competitor's instrument. The valved cannula was not retained during instrument retraction in the two active entry ports maintained by the cannula. There were no issues with the static port maintained by the synergetics infusion line. The inability of the cannula to be retained caused a delay in the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932402-2012-00001 |
| MDR Report Key | 2708768 |
| Report Source | 07 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-02-14 |
| Date Mfgr Received | 2012-02-14 |
| Device Manufacturer Date | 2010-03-10 |
| Date Added to Maude | 2012-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN REGAN |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal | 63368 |
| Manufacturer Phone | 6367945013 |
| Manufacturer G1 | SYNERGETICS, INC. |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23 GAUGE ONE STEP VALVED CANNULA |
| Generic Name | CANNULA |
| Product Code | HQB |
| Date Received | 2012-03-02 |
| Model Number | 58.23V |
| Catalog Number | 58.23V |
| Lot Number | 0020271 |
| Device Expiration Date | 2013-03-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS |
| Manufacturer Address | 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-02 |