inforMED
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

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.