MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-13 for * FORCE GSU-22 manufactured by Valleylab Incorporated Pfizer Hosp Prod Grp.
[102767]
Argon beam coagulator was used for a liver resection. Prior to the start of the case, they observed that one tank was low. They installed a new tank. Unit did not function during the case. It was observed that the output had an additional filter installed. This extra filter was removed but the unit would still not coagulate. Power was turned up with no success. Nurse supervisor noticed that the new tank that was installed was nitrogen, not argon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 132438 |
| MDR Report Key | 132438 |
| Date Received | 1997-11-13 |
| Date of Report | 1997-11-11 |
| Date of Event | 1997-11-05 |
| Date Facility Aware | 1997-11-05 |
| Report Date | 1997-11-11 |
| Date Reported to FDA | 1997-11-12 |
| Date Reported to Mfgr | 1997-11-12 |
| Date Added to Maude | 1997-11-18 |
| 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 |
| 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 | * |
| Generic Name | ARGON BEAM COAGULATION SYSTEM |
| Product Code | LMS |
| Date Received | 1997-11-13 |
| Model Number | FORCE GSU-22 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | ASSET TAG: 9807 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 129456 |
| Manufacturer | VALLEYLAB INCORPORATED PFIZER HOSP PROD GRP |
| Manufacturer Address | 5920 LONGBOW DRIVE PO BOX 9015 BOULDER CO 803013202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-11-13 |