MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for UNKNOWN 27178-B manufactured by Baxter Healthcare Corporation.
[18162437]
Cysto-scissors being used to open ureter, would not close, removed second pair completed procedureinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: component failure, none or unknown. Conclusion: device failure occurred but not related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1380 |
| MDR Report Key | 1380 |
| Date Received | 1992-07-01 |
| Date of Report | 1992-06-30 |
| Date of Event | 1992-05-26 |
| Date Facility Aware | 1992-05-26 |
| Report Date | 1992-06-30 |
| Date Reported to FDA | 1992-06-30 |
| Date Reported to Mfgr | 1992-06-03 |
| Date Added to Maude | 1992-09-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | CYSTO SCISSORS |
| Product Code | HRR |
| Date Received | 1992-07-01 |
| Model Number | 27178-B |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1323 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-01 |