FDA Adverse Event
Malfunction
Summary report: N
STORZ BIPOLAR ADAPTER
MDR report key: 41703
·
Received September 6, 1996
Report
- Report Number
- 1920664-1996-00611
- Event Type
- Malfunction
- Date Received
- September 6, 1996
- Date of Event
- July 22, 1996
- Report Date
- August 8, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR ADAPTER COULD NOT BE USED. ANOTHER ADAPTER OR GENERATOR WAS USED TO COMPLETE THE PROCEDURE. THREE ADAPTERS ARE BEING RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ BIPOLAR ADAPTER | BIPOLAR ADAPTER | HQO | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |