FDA Adverse Event
Injury
Summary report: N
GUIDANT 5MM ACHROMATIC SCOPE
MDR report key: 379318
·
Received February 27, 2002
Report
- Report Number
- 2953148-2002-00004
- Event Type
- Injury
- Date Received
- February 27, 2002
- Date of Event
- January 16, 2002
- Report Date
- January 16, 2002
- Manufacturer
- SCHOLLY FIBEROPTIC GMBH
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A SAPHENOUS VEIN HARVESTING PROCEDURE, CO2 EMBOLISM WAS NOTICED IN THE PATIENT'S LEFT THIGH. NO ADDITIONAL ADVERSE EFFECTS IN PATIENT WERE NOTICED BY THE SURGEON OR ANESTHESIOLOGIST. THE DEVICE IS NOT BEING RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT 5MM ACHROMATIC SCOPE | ENDOSCOPE | GCJ | SCHOLLY FIBEROPTIC GMBH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |