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

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.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12481108
• MDR Text Key: 271698866
• Report Number: 12481108
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205
• Device Catalogue Number: 471205
• Device Lot Number: K10210709 0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 81