FDA Adverse Event
Malfunction
Summary report: N
STELLARIS 25 GAUGE POSTERIOR VITRECTOMY CUTTER
MDR report key: 2993068
·
Received March 1, 2013
Report
- Report Number
- 1920664-2013-00040
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K101325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE USER FACILITY THEREFORE NO EVAL IS POSSIBLE. THE STERILIZATION AND LOT HISTORY RECORDS OF THIS DEVICE WERE REVIEWED AND FOUND TO BE ACCEPTABLE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM A USER FACILITY IN THE USA STATING THE VITRECTOMY CUTTER HAD INADEQUATE CUTTING ACTION DURING THE PROCEDURE. A REPLACEMENT CUTTER WAS USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE THE ORIGINAL CUTTER WAS TESTED AGAIN AND WAS FOUND TO FUNCTION NORMALLY. THERE WAS NO SERIOUS INJURY OR REPORT OF PERMANENT IMPAIRMENT RELATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89260 | STELLARIS 25 GAUGE POSTERIOR VITRECTOMY CUTTER | HQC | BAUSCH & LOMB, INC. | U9241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |