MalfunctionGAF
DAVINCI INTUITIVE SURGICAL SYSTEMS
Received Dec 21, 2011 · Event occurred Dec 13, 2011
Report MW5023591 · MDR key 2390198
Device
Generic name
Robotic Cautery Spatula
Manufacturer
Davinci SurgicalModel number
420484Catalog number
420484
Product problems
- Break
- Device Or Device Fragments Location Unknown
Patient
46 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHILE PERFORMING A ROBOTIC LUNG BIOPSY BY DR (B)(6). THE CAUTERY SPATULA HAD A PIECE OF IT COME OFF AT THE TIP CLOSEST TO THE END. MANY ATTEMPTS TO RETRIEVE IT WERE MADE (APPROX 20 MINUTES) AND ALL ATTEMPTS FAILED. SURGEON FELT IT WAS MORE POTENTIAL FOR HARM BY CONTINUING TO RETRIEVE THAN TO LEAVE IT RETAINED. SURGERY CONTINUED AS SCHEDULED AND WAS COMPLETED WITHOUT ANY FURTHER EVENTS. PLEASE NOTE THIS OCCURRED ON THE 4TH USE OUT OF 10 POSSIBLE USES OF THIS PRODUCT.