MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-18 for HYRDO-SURG PLUS HYDRO-SURGICAL IRRIGATOR 0026870 * manufactured by C.r. Bard, Inc..
[3173761]
During use, the hydro surg irrigator stopped working and started to smell like it was burning. The casing became hot. What was the original intended procedure? Laparoscopic supracervical hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2982146 |
| MDR Report Key | 2982146 |
| Date Received | 2013-02-18 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-09-06 |
| Report Date | 2012-11-15 |
| Date Reported to FDA | 2013-02-18 |
| Date Reported to Mfgr | 2013-02-28 |
| Date Added to Maude | 2013-02-28 |
| 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 | 3 |
| 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 | HYRDO-SURG PLUS HYDRO-SURGICAL IRRIGATOR |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | KQT |
| Date Received | 2013-02-18 |
| Model Number | 0026870 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |