FDA Adverse Event
Malfunction
Summary report: N
STORZ PROTEGE OPHTHALMIC MICROSURGICAL SYSTEM
MDR report key: 39626
·
Received September 9, 1996
Report
- Report Number
- 1920664-1996-00624
- Event Type
- Malfunction
- Date Received
- September 9, 1996
- Date of Event
- August 12, 1996
- Report Date
- August 13, 1996
- Manufacturer
- STORZ INSTRUMENT CO
- Product Code
- HQE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A VITRECTOMY PROCEDURE ON AN ANIMAL, THE VITRECTOMY FUNCTION OF THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT PULSE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED. THIS UNIT IS USED ON ANIMALS AT A RESEARCH FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ PROTEGE OPHTHALMIC MICROSURGICAL SYSTEM | OPHTHALMIC MICROSURGICAL SYSTEM | HQE | STORZ INSTRUMENT CO | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |