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 |