FDA Adverse Event
Malfunction
Summary report: N
STORZ PREMIERE OPHTHALMIC MICROSURGICAL SYSTEM
MDR report key: 42009
·
Received September 19, 1996
Report
- Report Number
- 1920664-1996-00651
- Event Type
- Malfunction
- Date Received
- September 19, 1996
- Date of Event
- August 22, 1996
- Report Date
- August 22, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HQE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UNIT CONTINUED TO IRRIGATE AFTER FOOT IS OFF THE FOOT PEDAL AND ON PHACO MODE. PRESSING ON THE FOOT PEDAL CAUSES THE SETTINGS ON THE SCREEN TO REVERT TO ZERO.
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 |