MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-12 for ENDO FMS UROLOGY PUMP CE-D197 manufactured by .
[1045831]
Using endo fms urology pump for bladder surgical procedure, and pump malfunctioned without any alarms and gave high pressure to fill bladder causing bladder tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010311 |
| MDR Report Key | 1343953 |
| Date Received | 2009-03-12 |
| Date of Report | 2009-03-12 |
| Date of Event | 2009-02-18 |
| Date Added to Maude | 2009-03-23 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO FMS UROLOGY PUMP |
| Generic Name | BLADDER IRRIGATOR |
| Product Code | KQT |
| Date Received | 2009-03-12 |
| Model Number | CE-D197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2009-03-12 |