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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471205
Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 08/30/2021
Event Type  malfunction  
Event Description
Narrative from staff: the surgeon was doing a colon resection with robotic assistance. We paused to add an assistant port. Arm number 2 began flashing yellow, screen on robot indicated a problem with the axis of the instrument. Instrument was not holding any patient tissue or working at the time. Attempted to use unlocking device to unlock the instrument, it worked as it should however was a non-essential action since the instrument was not locked on any tissue. Called the davinci tech support, ended up removing the entire instrument with the trocar. Unable to remove the instrument from the trocar. Instrument will be sent to davinci for investigation, procedure converted to open for extracorporeal completion of the surgery, intracorporal procedure was planned. Narrative from operative report: as i was preparing to take the middle colic vessel, the fenestrated bipolar forceps became stuck in the trocar and they were unable to get these out and so we decided to abort with the robot and finish up the extracorporeal anastomosis after making a small vertical midline incision which i did. The wound protector was placed into this incision and the transverse colon was then very easily able to come out with very sufficient length. I was able to palpate the polyp which was found to be in the tattoo and i then marked 6 cm proximal and distal to this as my intended colon transection point. I then ligated the mesentery including a high ligation of the middle colic artery which i was able to very easily see and palpate with it outside of the patient's abdomen. Hemostasis was ensured. Then utilized the gia stapler to staple across the proximal and distal portions of the transverse colon. Manufacturer response for davinci surgical fenestrated bipolar grasper, davinci (per site reporter): device was sent back to manufacturer for investigation.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12481108
MDR Text Key271698866
Report Number12481108
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 Other Health Care Professional
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205
Device Catalogue Number471205
Device Lot NumberK10210709 0285
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Event Location Hospital
Date Report to Manufacturer09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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