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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
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INTUITIVE SURGICAL, INC. SUREFORM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Event Description
During robotic procedure, surgical resident was operating the robot under the direction of the attending surgeon who was at the field.While using the sureform davinci xi 60 stapler, the stapler stalled while inside the patient during a procedure.The stapler was not clamped onto tissue at the time but the stapler would not move straight from it's angled position or open its jaws.The attending surgeon removed the stapler from the docked arm without using the release crank on the stapler.No injury to the patient was apparent at this time.The robot equipment vendor rep was also present.Manufacturer response for robotic stapler, sureform 60 stapler (per site reporter).The company rep was present in the room when the event occurred.
 
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Brand Name
SUREFORM
Type of Device
SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key8603411
MDR Text Key144833714
Report Number8603411
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2019
Event Location Hospital
Date Report to Manufacturer05/13/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/13/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age10585 DA
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