FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2770256
·
Received October 1, 2012
Report
- Report Number
- 1518293-2012-00180
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 10, 2012
- Report Date
- October 1, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IXR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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 DURING A UROLOGY PROCEDURE FOR BLADDER RESECTION (PT INFORMATION NOT PROVIDED), THE SYSTEM FLUORO FAILED. PHYSICIAN COMPLETED THE PROCEDURE USING ENDOSCOPY. PT IS FINE. NO REPORTED INJURY. CUSTOMER ALSO REPORTS AFTER THIS PROCEDURE WAS OUT OF THE ROOM, THEY FOLLOWED TECH SUPPORT INSTRUCTIONS FOR RESETTING THE IMAGING CHAIN AND THE ROOM IS NOW WORKING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | IXR | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |