FDA Adverse Event
Injury
Summary report: N
AMADEUS II
MDR report key: 3216777
·
Received July 2, 2013
Report
- Report Number
- 9614468-2013-00002
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- May 2, 2013
- Report Date
- July 1, 2013
- Manufacturer
- SIS LTD. SURGICAL INSTRUMENT SYSTEMS
- Product Code
- HNO
- PMA / PMN Number
- K043150
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
MICROKERATOME MOTOR UNIT STOPPED DURING LASIK FLAP CUT; INCOMPLETE FLAP; CORROSION AND RESIDUES FOUND ON INTERNAL COMPONENTS; FAILURE CAUSED BY INADEQUATE CLEANING OF MOTOR UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300697 | AMADEUS II | AMADEUS II MOTOR UNIT | HNO | SIS LTD. SURGICAL INSTRUMENT SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |