FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2093550
·
Received April 5, 2011
Report
- Report Number
- 1518293-2011-00056
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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): OPERATING ROOM NURSE, REPORTS FEMALE (AGE NOT PROVIDED) HAVING A STENT PLACEMENT PROCEDURE WHEN FLUORO FAILED. NURSE REPORTS, THE PHYSICIAN HAD TO BLINDLY PLACE THE STENT. SHE WAS NOT AWARE OF ANY REPERCUSSIONS. NURSE WOULD NOT PROVIDE ANY FURTHER INFORMATION OR CONTACT FOR PM FOLLOW UP ON PATIENT OUTCOME. ON (B)(6): CUSTOMER REPORTED THAT DURING A STENT PLACEMENT, THE SYSTEM WOULD NOT FLUORO. PHYSICIAN WAS UNABLE TO VERIFY STENT PLACEMENT ON THE SYSTEM. PATIENT WAS TRANSFERRED TO RECOVERY WHERE STENT PLACEMENT WAS VERIFIED WITH X-RAY. NO PATIENT INJURY WAS 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 |