FDA Adverse Event
Malfunction
Summary report: N
LID SPECULUM
MDR report key: 120686
·
Received September 15, 1997
Report
- Report Number
- 1932180-1997-00079
- Event Type
- Malfunction
- Date Received
- September 15, 1997
- Date of Event
- August 18, 1997
- Report Date
- August 18, 1997
- Manufacturer
- STORZ INSTRUMENT COMPANY
- Product Code
- HNC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS SPECULUM BROKE DURING A CATARACT PROCEDURE. THERE WAS NO PT INJURY. ANOTHER SPECULUM WAS USED FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LID SPECULUM | SPECULUM | HNC | STORZ INSTRUMENT COMPANY | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |