MalfunctionNAY
DA VINCI XI SYSTEM FENESTRATED BIPOLAR FORCEPS
Received Feb 19, 2016 · Event occurred Oct 6, 2015
Report 5446453 · MDR key 5446453
Device
Generic name
System,surgical,computer Controlled Instrument
Manufacturer
Intuitive Surgical S. De R.l. De C.v.Model number
XICatalog number
470205
Lot number
S10150313 0057
Product problems
- Device Or Device Fragments Location Unknown
Patient
66 YR
- No Information
- No Information
Narrative
Description of Event or Problem
XI DAVINCI FENESTRATED BIPOLAR MISSING 1MMX1MMX3MM PLASTIC PIECE OF INSULATION ON TIP OF INSTRUMENT - UNKNOWN IF LOST IN PT OR BEFORE INSERTED IN PT. IN THIS CASE, THERE WERE NO VISIBLE PIECES OF THE PLASTIC COVERING SEEN IN PATIENT. THE MISSING PORTION WAS NOTED AFTER IT WAS REMOVED SINCE THE JAWS OF THE INSTRUMENT WOULD NOT OPERATE PROPERLY. DUE TO THE SMALL SIZE; HOWEVER, IT COULD NOT BE DETERMINED IF IT WAS REMOVED THROUGHOUT THE COURSE OF NORMAL IRRIGATION AND SUCTIONING DURING THE SURGERY.