MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-18 for STORZ * manufactured by Karl Storz Endoscopy-america, Inc..
[21237391]
The case was proceeding well, and there was no fluid deficit (minus the 100ml on floor). The intrauterine tissue removal portion of the case was started and it was noted that the amount of positive deficit (meaning more fluid than less) was noted to climb steadily. The patient was stable and there were no concern from doctor as the fluid was clear with only a hint of blood noted in fluid. The circulator continued to monitor and keep surgeon informed. The intake and output noted via observation and calculation showed there was no additional fluid. At that point, a scale was obtained and all fluids were weighed and it was calculated that there was a 300ml deficit and not an addition of fluid. A work order was put in to have the fluid management system checked and calibrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4489968 |
| MDR Report Key | 4489968 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-11-18 |
| Date of Event | 2014-10-10 |
| Report Date | 2014-11-18 |
| Date Reported to FDA | 2014-11-18 |
| Date Reported to Mfgr | 2015-02-06 |
| Date Added to Maude | 2015-02-06 |
| 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 | STORZ |
| Generic Name | FLUID MANAGEMENT SYSTEM |
| Product Code | LTA |
| Date Received | 2014-11-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-18 |