MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-11 for HYDRO-SURG PLUS * 0026880 manufactured by Davol Inc..
[15630288]
The suction irrigator was leaking from the battery pack. No harm to staff or patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317630 |
| MDR Report Key | 1317630 |
| Date Received | 2009-02-11 |
| Date of Report | 2009-02-11 |
| Date of Event | 2009-01-23 |
| Report Date | 2009-02-11 |
| Date Reported to FDA | 2009-02-11 |
| Date Added to Maude | 2009-02-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HYDRO-SURG PLUS |
| Generic Name | IRRIGATOR, LAPAROSCOPIC, BATTERY POWERED |
| Product Code | KQT |
| Date Received | 2009-02-11 |
| Model Number | * |
| Catalog Number | 0026880 |
| Lot Number | JUSDF003 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC. |
| Manufacturer Address | A SUBDIVISION OF C.R. BARD, IN 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US 02920 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-11 |