FDA Adverse Event
Injury
Summary report: N
SUPERDIMENSION INREACH BRONCHUS SYSTEM
MDR report key: 3796633
·
Received April 23, 2014
Report
- Report Number
- 3004962788-2014-00027
- Event Type
- Injury
- Date Received
- April 23, 2014
- Date of Event
- March 28, 2014
- Report Date
- April 23, 2014
- Manufacturer
- SUPERDIMENSION INC.
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUPERDIMENSION IS NOT EXPECTING A RETURN DEVICE FROM THE SITE FOR EVALUATION. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.
Description of Event or Problem · 1
SITE REPORTED A PNEUMOTHORAX POST SUPERDIMENSION PROCEDURE. PATIENT RECEIVED CHEST TUBE AND WAS HOSPITALIZED 2 NIGHTS AND DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244711 | SUPERDIMENSION INREACH BRONCHUS SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION INC. | AAS00161-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| O |