MalfunctionNAY
DAVINCI XI CAUTERY HOOK
Received Apr 11, 2016 · Event occurred Dec 2, 2015
Report 5566710 · MDR key 5566710
Device
Generic name
System,surgical,computer Controlled Instrument
Manufacturer
Intuitive Surgical S. De R.l. De C.v.Catalog number
470183
Lot number
S10150804 0042
Product problems
- Break
Patient
59 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
TIP OF DAVINCI CAUTERY HOOK HAS A HARD PLASTIC COATING THAT CHIPPED OFF WHEN INSTRUMENTS COLLIDED IN ABDOMEN. THE MATERIAL ITSELF IS NOT RADIOPAQUE SO X-RAY WOULD NOT BE ABLE TO LOCATE FOREIGN BODY IF STILL IN ABDOMEN. ALSO THE PIECE IS SO SMALL IT COULD HAVE EASILY BEEN SUCTIONED UP DURING THE IRRIGATION PROCESS. INSTRUMENT HAS BEEN REMOVED FROM SERVICE AND WILL BE HELD BY MYSELF IN CASE ANY FURTHER INVESTIGATION IS NEEDED AND WILL LATER BE RETURNED TO INTUITIVE SURGICAL FOR FURTHER STUDY AND CREDIT.