MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-11 for MERRIMAN-GRAVES MEDICAL PRODUCTS E-CYLINDER UN 1013 manufactured by Merriman-graves Medical.
[170556]
Laparoscopic cholecystectomy performed using co2 for inflation of abdomen. Fog developed in abdomen (2nd class) cleared somewhat but not completely when inflation port changed. Co2 cylinder check: o2=concentration 0%; co2=none detected, -43%=dew point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 301755 |
| MDR Report Key | 301755 |
| Date Received | 2000-10-11 |
| Date Facility Aware | 2000-09-22 |
| Date Reported to FDA | 2000-10-06 |
| Date Reported to Mfgr | 2000-10-06 |
| Date Added to Maude | 2000-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERRIMAN-GRAVES MEDICAL PRODUCTS |
| Generic Name | CO2 CYLINDER |
| Product Code | KGA |
| Date Received | 2000-10-11 |
| Model Number | E-CYLINDER |
| Catalog Number | UN 1013 |
| Lot Number | C |
| ID Number | * |
| Device Expiration Date | 2004-12-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 292057 |
| Manufacturer | MERRIMAN-GRAVES MEDICAL |
| Manufacturer Address | 806 RIVER RD. CHARLESTOWN NH 036304150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-11 |