FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 400VS
MDR report key: 1921946
·
Received December 8, 2010
Report
- Report Number
- 2028159-2010-02326
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 8, 2010
- Report Date
- November 8, 2010
- 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
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED BY THE MFR, BUT HAS NOT BEEN EVALUATED YET. THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT THE SYSTEM WOULD NOT ACCEPT THE CASSETTE AND DISPLAYED A SYSTEM MESSAGE. THEY WERE ABLE TO REINSERT THE CASSETTE AND COMPLETE THE CASE AFTER A 15 MINUTE DELAY. NO HARM TO THE PT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 400VS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |