FDA Adverse Event
Injury
Summary report: N
GUIDANT 5MM ACHROMATIC SCOPE
MDR report key: 381014
·
Received March 7, 2002
Report
- Report Number
- 2953148-2002-00007
- Event Type
- Injury
- Date Received
- March 7, 2002
- Date of Event
- February 4, 2002
- Report Date
- February 28, 2002
- Manufacturer
- SCHOLLY FIBEROPTICS, GMBH
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED CO2 EMBOLISM TO THE PT DURING SAPHENOUS VEIN HARVESTING PROCEDURE. IT WAS REPORTED THAT THE CO2 GAS REACHED THE HEART THROUGH THE VEINS. NO PT COMPLICATIONS OR NEUROLOGICAL DAMAGE TO THE PT WAS REPORTED. THE DEVICE WAS DISCARDED BY THE CUSTOMER AND IS NOT COMING BACK. NO PRODUCT PERFORMANCE CLAIMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT 5MM ACHROMATIC SCOPE | ENDOSCOPE | GCJ | SCHOLLY FIBEROPTICS, GMBH | 11333 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |