FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 800CS
MDR report key: 1230410
·
Received November 7, 2008
Report
- Report Number
- 2028159-2008-00405
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 10, 2008
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON WILL BE RETURNING THE VITRECTOMY PROBE FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 11/07/2008.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT DURING SURGERY THE VITRECTOMY PROBE BROKE IN THE PATIENT'S EYE. THE SURGEON SWITCHED OUT THE PROBE AND COMPLETED THE CASE AS PLANNED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 800CS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |