FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 400VS
MDR report key: 2072403
·
Received April 8, 2011
Report
- Report Number
- 2028159-2011-00335
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 10, 2011
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A VITRECTOMY PROCEDURE, THE SILICONE OIL INFUSION DID NOT WORK. A SYSTEM REBOOT WAS PERFORMED; HOWEVER, A SYSTEM MESSAGE DISPLAYED. ANOTHER REBOOT WAS PERFORMED, BUT THE ISSUE PERSISTED AND THERE WAS NO VACUUM. THE SURGEON MANUALLY INJECTED THE SILICONE OIL TO COMPLETE THE PROCEDURE FOLLOWING A 30 MINUTE DELAY. THERE WAS NO HARM OR INJURY TO THE PATIENT.
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 |