FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 1193524
·
Received October 9, 2008
Report
- Report Number
- 1518293-2008-00291
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 10, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIEBEL FLARSHEIM MANUFACTURING REPORT: CUSTOMER REQUESTED THAT LF ONLY SEND TO THEIR SITE THE PART THAT THE CUSTOMER HAS DETERMINED CAUSED THE EVENT, THE FOOTSWITCH, INSTEAD OF THE LF FIELD SERVICE ENGINEER PROVIDING SERVICE AND EVALUATION OF THE SYSTEM. THE FSE CONTACTED THE O. R. DIRECTOR, AND CUSTOMER CONFIRMED SYSTEM WAS OPERATING PROPERLY WITH THE REPLACEMENT FOOTSWITCH. THE FSE ALSO CONTACTED FACILITY, WHO DENIED RETURN TO COVIDIEN OF THE FOOTSWITCH THAT WAS REPLACED.
Description of Event or Problem · 1
CUSTOMER REPORTS PATIENT UNDERGOING CYSTOGRAM WITH POSSIBLE STENT PLACEMENT WHEN FLUORO FAILED, DURING THE PROCEDURE. PROCEDURE WAS COMPLETED UTILIZING RADIOGRAPHIC IMAGES. NO PT INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |