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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVINCI - INTUITIVE DAVINCI SI
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DAVINCI - INTUITIVE DAVINCI SI Back to Search Results
Model Number SI
Device Problems Device Slipped (1584); Mechanical Jam (2983); Unintended Movement (3026)
Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)
Event Date 05/18/2015
Event Type  Injury  
Event Description
Arm/ of the davinci machine would not release the instrument.The assistant tried to remove the instrument and the instrument shipped, causing a superficial laceration of the liver.Cautery was used to stop the bleeding.I came by yesterday to look at arm 1 for instruments sticking when trying to be remove them.I had my instruments sticking a little bit on arm 1 also.I found three of the plunger pin holders had come unscrewed about halfway.Which was causing the instruments to be released at an angle and that was causing them to stick when being released.After tightening down the plunger pin holders my instruments came out very smoothly with no sticking.I'm not sure if the problem they had on monday was entirely caused by the plunger pins being backed out or a combination of the pins and maybe a bad sterile adapter.
 
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Brand Name
DAVINCI SI
Type of Device
DAVINCI SI
Manufacturer (Section D)
DAVINCI - INTUITIVE
sunnyvale CA
MDR Report Key4802340
MDR Text Key5922384
Report NumberMW5042851
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSI
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age40 YR
Patient Weight77
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