FDA Adverse Event
Malfunction
Summary report: N
MERRIMAN-GROVES MEDICAL PRODUCTS
MDR report key: 301773
·
Received October 11, 2000
Report
- Report Number
- 301773
- Event Type
- Malfunction
- Date Received
- October 11, 2000
- Date of Event
- September 21, 2000
- Report Date
- October 6, 2000
- Manufacturer
- MERRIMAN-GRAVES MEDICAL
- Product Code
- KGA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED USING CO2 FOR INFLATION OF ABDOMEN. FOG DEVELOPED IN ABDOMEN (FIRST CASE). FURTHER TESTING ON TANK BY CO RESULTS; O2 CYLINDER CHECK, O2 CONCENTRATION - 0%, CO - NON DETECTED, - 43 DEGREE - DEW POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERRIMAN-GROVES MEDICAL PRODUCTS | CO2 CYLINDER | KGA | MERRIMAN-GRAVES MEDICAL | E CYLINDER | C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |