SUPERTRAX BIOPSY FORCEPS
Received Jun 7, 2016 · Event occurred Apr 22, 2016
Report 3004962788-2016-00135 · MDR key 5702877
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR
- Pneumothorax
- Pneumothorax
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INSPECTION RECORD WAS REVIEWED AND THERE WERE NO ANOMALIES OBSERVED ASSOCIATED TO THIS ISSUE. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AFTER A SUPERDIMENSION ENB PROCEDURE THE PATIENT BECAME TACHYCARDIC AND TACHYPNEIC. A CHEST X-RAY WAS PERFORMED AND THE PATIENT HAD A LEFT TENSION PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND ONE HOUR LATER THE PATIENT IMPROVED. IF ADDITIONAL INFORMATION IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.