MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-11-22 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2505611]
On (b)(6) 2011: customer reports via phone that during a ureteroscopy on a male patient under anesthesia the fluoro failed. Staff had to move patient to another room and complete the procedure using a portable fluoro c-arm. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9492474]
Field service engineer (fse) found there was no fluoro when the foot control was pressed. When fse reset power to the generator, the system functioned properly. Fse monitored system for a few days, returning to site on (b)(4)-2011 and verified there were no further problems with the system. Fse completed system checkout using service checklist qssrwi4. 1 and returned the system to full service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00233 |
| MDR Report Key | 2363049 |
| Report Source | 06,07 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-04 |
| Date Mfgr Received | 2011-11-04 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2012-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-22 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-22 |