MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-23 for X-STEAM 5MM X 33CM 5552002 manufactured by Bard-davol.
[16452483]
Bard-davol x-stream laparoscopic irrigation tubing set with nezhat-dorsey trumpet valve would not function. The power light was on, but the high/low light was not. Another base unit was tried with the same result. A "like" device was subsequently opened and worked without issue in the initial base unit. Diagnosis or reason for use: laparoscopic cholecystectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034006 |
| MDR Report Key | 3599237 |
| Date Received | 2014-01-23 |
| Date of Report | 2014-01-21 |
| Date of Event | 2014-01-21 |
| Date Added to Maude | 2014-01-31 |
| 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 |
| 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 | X-STEAM 5MM X 33CM |
| Generic Name | LAPAROSCOPIC IRRIGATOR |
| Product Code | KQT |
| Date Received | 2014-01-23 |
| Model Number | 5552002 |
| Catalog Number | 5552002 |
| Lot Number | JUXJF431 |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD-DAVOL |
| Manufacturer Address | WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-23 |