FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2191263
·
Received July 19, 2011
Report
- Report Number
- 1518293-2011-00126
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ON 07/13: STAFF TECHNOLOGIST REPORTS AN APPROXIMATELY (B)(6) FEMALE PT WAS HAVING A URETEROSCOPY WITH STENT PLACEMENT UNDER GENERAL ANESTHESIA WHEN THE SYSTEM FLUORO FAILED. STAFF MOVED THE PT TO ANOTHER ROOM WHERE THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-REVERSE | UROLOGY SYSTEM | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |