FDA Adverse Event
Death
Summary report: N
SUPERDIMENSION INREACH SYSTEM
MDR report key: 2877379
·
Received December 14, 2012
Report
- Report Number
- 3004962788-2012-00048
- Event Type
- Death
- Date Received
- December 14, 2012
- Date of Event
- November 15, 2012
- Report Date
- December 14, 2012
- Manufacturer
- SUPERDIMENSION, INC.
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD, CONCLUSIONS: NO DEVICE WAS RETURNED FOR EVALUATION. THE SITE HAS SUBSEQUENTLY COMPLETED CASES WITHOUT ANY ADVERSE EVENTS SINCE THIS REPORTED EVENT.
Description of Event or Problem · 1
SITE REPORTED PHYSICIAN WAS ABLE TO NAVIGATE AND SAMPLE WITH THE SUPERDIMENSION INREACH SYSTEM. THE MANAGER OF THE HOSPITAL UNIT CONTACTED SUPERDIMENSION ON (B)(6) 2012 AND STATED THERE WAS AN ADVERSE EVENT SHORTLY AFTER THE CONCLUSION OF THE CASE AND THE PATIENT PASSED AWAY. THE PHYSICIAN STATED THE PATIENT HAD UNDERLYING CHRONIC RESPIRATORY DISEASE AND DOES NOT ATTRIBUTE THE EVENT TO THE SUPERDIMENSION DEVICE OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPERDIMENSION INREACH SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION, INC. | AAS00161-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |