MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-05 for R. WOLF CO2 YOKE PART# 2026-64 * manufactured by Richard Wolf Medical Instruments.
[22072666]
The short indexing pins allowed a nitrous oxide bottle to be clamped in a co2 yoke for insufflation without a leak. Therefore, nitrous oxide was insufflated into the pt's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028350 |
| MDR Report Key | 458651 |
| Date Received | 2003-05-05 |
| Date of Report | 2003-05-05 |
| Date of Event | 2003-04-01 |
| Date Added to Maude | 2003-05-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R. WOLF CO2 YOKE |
| Generic Name | YOKE/CLAMP |
| Product Code | CAM |
| Date Received | 2003-05-05 |
| Model Number | PART# 2026-64 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 447614 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-05-05 |