FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2023134
·
Received February 24, 2011
Report
- Report Number
- 9617766-2011-00442
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 4, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE AND THE CABLE STRAIN RELIEF MECHANISM. NO CONCLUSION CAN BE DRAWN AS STATUS OF FINAL REPAIRS IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE INTERCONNECT CABLE WAS BROKEN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |