FDA Adverse Event
Malfunction
Summary report: N
SUPERDIMENSION INREACH SYSTEM
MDR report key: 2971851
·
Received February 15, 2013
Report
- Report Number
- 3004962788-2013-00004
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 15, 2013
- Manufacturer
- SUPERDIMENSION INC.
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SITE DID NOT RETURN ANY COMPONENT OF THE SUPERDIMENSION SYSTEM FOR EVALUATION. A REVIEW OF THE DHR FOR THE SYSTEM FOUND NO ANOMALIES. SUPERDIMENSION IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO ADDITIONAL RISKS ASSOCIATED WITH MULTIPLE EXPOSURES TO ANESTHESIA.
Description of Event or Problem · 1
SITE REPORTED DIFFICULTY POWERING AND LOGGING INTO THE SYSTEM. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED AND THE PT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69528 | SUPERDIMENSION INREACH SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION INC. | AAS00161-12C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |