FDA Adverse Event
Malfunction
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 1052559
·
Received May 22, 2008
Report
- Report Number
- 2028159-2008-00183
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Report Date
- April 22, 2008
- Manufacturer
- ALCON - IRVIN TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED FOOTPEDAL WAS VISUALLY INSPECTED AND FOUND TO HAVE HEAVY WEAR. THE STRAIN RELIEF OF THE FOOTPEDAL CABLE WAS NOT IN ITS ORIGINAL PLACE. THE FOOTPEDAL WAS TESTED AND MET ALL FUNCTIONAL SPECIFICATIONS INCLUDING GROUND ISOLATION AND GROUND RESISTANCE. A REVIEW OF COMPLAINTS AND SERVICE DATA FOR BOTH THE SYSTEM AND FOOTPEDAL INDICATES THAT THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. COMPLAINT TRENDING INDICATES NO RECENT ADVERSE TRENDS ASSOCIATED WITH THE COMPLAINT. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED IN THIS INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT FOOTSWITCH HAD A SHORT IN IT. TWO CASES WERE CANCELLED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTALMIC SURGERY SYSTEM | HQE | ALCON - IRVIN TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |