FDA Adverse Event
Malfunction
Summary report: N
STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM
MDR report key: 41997
·
Received September 19, 1996
Report
- Report Number
- 1920664-1996-00645
- Event Type
- Malfunction
- Date Received
- September 19, 1996
- Date of Event
- August 20, 1996
- Report Date
- August 20, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HQE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
ALL KEY SWITCHES ON THE FRONT PANEL OF THIS UNIT HAVE CEASED TO FUNCTION. ANOTHER UNIT WAS USED FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM | OPHTHALMIC MICROSURGICAL SYSTEM | HQE | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |