MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-01-09 for ONE STEP CANNULA 58.23 manufactured by Synergetics.
[96813317]
Cannula is broken in middle of polyimide tubing with sharp fracture. Glue joint and hub are fully intact. Fracture on yellow polyimide tube appears that an instrument caught the cannula causing the cannula to tear. Failure is not systemic and is not caused by any manufacturing defect. This failure was caused by user damage during surgery. Reviewed manufacturing batch records and found not anomalies. This is the only failure of this type this year which indicates a less than 1 in 5000 failure rate. Failure is not systemic and is not a manufacturing defect. Failure was caused by damage during surgery. Polyimide tubing is plastic and damage during surgery is possible.
Patient Sequence No: 1, Text Type: N, H10
[96813318]
A trocar broke during surgery and fell into the vitreous. An unplanned second surgery was required to remove the trocar piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932402-2018-00001 |
| MDR Report Key | 7177519 |
| Report Source | FOREIGN |
| Date Received | 2018-01-09 |
| Date of Report | 2018-01-02 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2015-11-06 |
| Date Added to Maude | 2018-01-09 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN REGAN |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O FALLON MO 63369 |
| Manufacturer Country | US |
| Manufacturer Postal | 63369 |
| Manufacturer Phone | 6367945013 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O FALLON MO 63369 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63369 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE STEP CANNULA |
| Generic Name | OPHTHALMIC CANNULA |
| Product Code | NGY |
| Date Received | 2018-01-09 |
| Model Number | 58.23 |
| Catalog Number | 58.23 |
| Lot Number | M548780 |
| Device Expiration Date | 2018-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS |
| Manufacturer Address | 3845 CORPORATE CENTRE DRIVE O FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-09 |