FDA Adverse Event
Other
Summary report: N
SCOPE, 5MM CUSTOM EXTENDED LENGTH
MDR report key: 241754
·
Received September 16, 1999
Report
- Report Number
- 2939738-1999-00032
- Event Type
- Other
- Date Received
- September 16, 1999
- Date of Event
- August 18, 1999
- Report Date
- September 1, 1999
- Manufacturer
- GUIDANT CORP., CARDIAC & VASCULAR SURGERY GRP., ORIGIN MEDSYSTEMS, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SCOPE, VERY CLOUDY. IT HAPPENED AUG. 18, PT CONVERTED TO OPEN PROCEDURE. PT RECOVERY AND DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCOPE, 5MM CUSTOM EXTENDED LENGTH | SCOPE | GCJ | GUIDANT CORP., CARDIAC & VASCULAR SURGERY GRP., ORIGIN MEDSYSTEMS, INC. | OMS-5LSSO | 121197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |