MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-14 for SYNERGETICS INFUSION CHANDLIER 56.30.25P manufactured by Synergetics.
[16217582]
The infusion endo-illuminator became occluded during insertion in a vitrectomy procedure. The patient's iop went into the hypotony range. The surgeon removed the suspect infusion endo-illuminator and replaced it with an endo-illuminator from the same lot. The surgeon proceeded as planned with no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932402-2013-00002 |
| MDR Report Key | 3266965 |
| Report Source | 07 |
| Date Received | 2013-03-14 |
| Date of Report | 2013-03-14 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-03-01 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2013-08-07 |
| 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 | 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 |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGETICS INFUSION CHANDLIER |
| Generic Name | INFUSION ENDO-ILLUMINATOR |
| Product Code | MPA |
| Date Received | 2013-03-14 |
| Returned To Mfg | 2013-03-05 |
| Model Number | 56.30.25P |
| Catalog Number | 56.30.25P |
| Lot Number | 0050305 |
| Device Expiration Date | 2013-08-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2013-03-14 |