MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; STAPLE, IMPLANTABLE

Model Number 480545

Device Problems Retraction Problem (1536); Failure to Advance (2524); Misfire (2532); Device Displays Incorrect Message (2591); Failure to Fire (2610)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Narrative from staff: doctor was using the x1 sureform 45 stapler and it misfired twice.Surgeon fired a green load and it cut the tissue and partial stapled causing some bleeding.When the staple load was removed, the blade did not completely retract.A second new stapler was opened, and surgeon fired with a black load and the same issue occurred.A second black load was opened, and the pa inserted the stapler and could not advance due to an error code stating the stapler could not be fired.A third stapler was opened, and it worked fine for the rest of the case.Patient did have some bleeding due the issue and the surgeon was able to stop it in a timely manner.Narrative from operative report: while completing the fissure between the upper and middle lobes again with the robotic stapler, the robotic stapler misfired.It appeared that the knife fight between tissue with incomplete seal and the remaining tissue was pushed out of the staple jaws.I requested for a new robotic sureform stapler and this was used again with similar result.Surgeon was unsure as to why this was happening, and the robotic company was also informed about this problem.These devices were saved and will later be sent to the company representative for additional investigation.Surgeon was then able to complete the fissure using a 3rd robotic stapler which fired without any technical problems.Minor oozing from the staple was controlled with robotic bipolar electrocautery.The specimen was placed in endo-catch bag and removed via the assistant port.A pexy maneuver was also performed between the middle and lower lobes to minimize risk of middle lobe torsion.Manufacturer response for staple, implantable, sureform (per site reporter): uknown.

• Brand Name: SUREFORM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 11840744
• MDR Text Key: 251143453
• Report Number: 11840744
• Device Sequence Number: 1
• Product Code: GDW
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480545
• Device Catalogue Number: 480545
• Device Lot Number: L92201215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 68