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

Model Number 470298

Device Problems Failure to Fire (2610); Mechanical Jam (2983); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

The surgeon was using the 45-degree xi robotic stapler and when he closed the stapler in preparation to fire the staple load, it threw an error code that said it was unable to fire.The surgeon opened and removed the stapler and reload, and the stapler was red tagged and removed from the field.He took a picture of what it looked like after he removed the staple reload without it successfully firing.A new stapler was opened to the field for use.From the procedural note: "left lung was taken off of the ventilatory circuit and the staple line was deployed.At this point, i was simply left with the superior aspect of the major fissure to complete.I chose a robotic power-assisted green load stapler.The stapler was positioned and deployed without any issue.I then fired the stapler and halfway through, received an error message that the stapler had jammed.I was able to release the stapler.As messaged, i identified the location of the blade within the staple.This was visualized and the entire stapler was removed out of the robotic port without incident.I examined this portion of the parenchyma in this heavy anthracotic lung.There were some staples that did not deploy, and these were manually removed.At this point, i obtained a power-assisted medtronic thick tissue black load 45mm stapler.This was positioned over and more proximally to the prior-placed staple line.This was clamped and deployed without any challenge.The stapler was removed.Utilizing 2 rolled gauzes for traction, i examined the area of the bronchial stump, which was intact.Just superior to this area with a double staple line that was placed over the failed staple line, i did see some air leak from the surrounding emphysematous parenchyma.The staple line itself was intact.This area was marked.All of the water was evacuated, and the left lung was taken off of the ventilatory circuit.Examination of this area demonstrated some weakening of the lung adjacent to the secondary staple line that was the cause of this air leak location.This could not be hand-tied or reinforced with bolstered stitches for concern over further tearing this lung.I elected to create a pleural tent and glue this onto the lung.The parietal pleura from the upper half of the chest was then mobilized with monopolar cautery.I kept the medial attachments intact for vascular supply.I mobilized this pleural tent wide and long enough to easily drape it over the area of the bronchial stump as well as at superior area of parenchymal air leak.After positioning this, one application of progel was placed on the lung and the pleural tent was glued down over this area.Positive pressure was held for 3 minutes.Following this, 2 additional applications of progel were placed at 3-minute intervals around the entire pleural tent and up superior segment of the lower lobe.After a final cure, the chest was filled with water and the lung was placed back in the circuit and charged up to 20cm.I did not appreciate any air leak.The lung was taken off of the ventilatory circuit and all the water was aspirated dry.At the completion of this operation, i could not appreciate any evidence of an air leak at 20cm of suction." there were no complications.

• 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: 10641327
• MDR Text Key: 210203364
• Report Number: 10641327
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2020

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
• Device Model Number: 470298
• Device Catalogue Number: 470298
• Device Lot Number: T10190211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 67