FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2974035
·
Received February 19, 2013
Report
- Report Number
- 1518293-2013-00036
- Event Type
- Malfunction
- Date Received
- February 19, 2013
- Date of Event
- January 28, 2013
- Report Date
- February 19, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IXR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 (B)(6): CUSTOMER REPORTS VIA PHONE THAT STAFF WERE PERFORMING A URETEROSCOPY WITH STENT PLACEMENT ON A MALE PT (AGE UNK), WHEN THE SYSTEM FLUORO FAILED. STAFF MOVED THE PT TO ANOTHER ROOM WHERE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. PT IS FINE, NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73232 | HUT EXT DR FINAL ASSY-STANDARD | IXR | LIEBEL-FLARSHEIM CO. | HUT EXT DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |