ULTRACORE BIOPSY NEEDLE 18GA X 16CM
Received Dec 12, 2024 · Event occurred Sep 14, 2024
Report 0001625425-2024-01171 · MDR key 20915713
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Male
- Pneumothorax
- Pneumothorax
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED. NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR EVALUATION. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE WAS SUBMITTED THAT WOULD HAVE ALLOWED THIS ALLEGATION TO BE REVIEWED. WITHOUT THE NECESSARY EVIDENCE, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. DETERMINING A ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLES ARE RETURNED AT A LATER DATE, THEN THIS COMPLAINT MAY BE REOPENED FOR RE-EVALUATION.
Description of Event or Problem
ON (B)(6) 2024, THE PATIENT UNDERWENT PERCUTANEOUS LUNG BIOPSY IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. POSTOPERATIVE CT IMAGES SHOWED THAT THE PATIENT DEVELOPED A SMALL AMOUNT OF PNEUMOTHORAX. FIVE MINUTES LATER, A CHEST X-RAY CT SCAN WAS PERFORMED, AND THE CT IMAGE SHOWED NO SIGNIFICANT CHANGES IN PNEUMOTHORAX. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD SAFELY. THE HOSPITAL REPORTED THIS CASE TO NMPA.