MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45 RELOAD BLUE

Model Number 48645B-04

Device Problems Retraction Problem (1536); Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted esophagectomy transthoracic (chest anastomosis) surgical procedure, the customer reported that the stapler 45 reload blade was only halfway through after the fire cycle was completed.As a result, partial fire issue occurred, and part of the staple line was not stapled.The surgeon elected to use a third-party stapler to complete the surgical task.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the stapler and reload were inspected prior to use with no issue.The issue occurred on the first fire.The stapler fire cycle was completed.The surgeon was trying to staple the esophagus.The tissue was not calcified and was not exposed to any radiation or chemotherapy prior to the procedure.There was no tissue tension.Tissue compression was performed multiple times.B-shaped staples were formed up to the blade exposure position, but beyond this location, several staples were unformed.Missing staples from the staple line was observed.No hole/gap observed within the staple line.The reload was not stuck to the tissue.The surgeon used the third-party stapler to complete the stapling task.No unplanned tissue was removed due to the issue.No error message appeared at the time of the event.The surgeon did not encounter any obstructions between the instrument jaws.The surgeon did not fire over an existing staple line.Buttress material was not used.The surgeon did not experience any clamping issue prior to firing the stapler reload.There was no unexpected bleeding.There was no procedure delay.The procedure was completed robotically.

Manufacturer Narrative

The stapler 45 reload has not been returned for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.During the esophagectomy transthoracic (chest anastomosis) surgical procedure, the stapler displayed a message indicating, ¿verify the sheath has been installed." there was no clamping or firing attempted on the first install and the stapler was and is reinserted for use.Prior to firing the reload on the second install, there were five incomplete clamp attempts.The completion percentages for these clamps were ~77%, ~84%, ~94%, ~94%, ~94%, respectively.The clamp hold times were either two or three seconds in duration before failing.The last clamp was logged as incomplete at ~94% completion and there was a completed unclamp in the logs ~6 seconds later (the only unclamp of the procedure).The sixth clamp of this install was completed and was followed by the firing of the blue reload.The firing was completed and there were also no stapler related errors in the logs.The user was able to unclamps and normal well-formed staple lines extending roughly halfway across the target tissue were observed.The reload blade was exposed and appeared to have deployed to roughly the 35mm mark on the endowrist (ew) stapler before stopping.There does not appear to be any sort of tissue damage or bleeding as a result of this interrupted fire.There were some unformed staples on the back side of the target tissue and were removed using the cadiere forceps.A third party laparoscopic stapler was inserted and continued the previous ew staple line.The stapler fired successfully and there was no apparent tissue injury or bleeding from the staple line.This complaint is considered a reportable event due to the following conclusion: it was reported that the stapler 45 reload blade was only halfway through after the fire cycle was completed.As a result, partial fire issue occurred, and part of the staple line was not stapled.Malformed staples and missing staples may contribute to an incomplete staple line.If not recognized during the procedure, medical intervention, including additional surgical procedures, may be required in the event that the staples are not delivered from the reload.At this time, it is unknown what caused the event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on the claim against the stapler 45 blue reload by the customer noting the blade was only halfway through after a completion of a fire cycle, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 45 blue reload was analyzed and found to have the knife exposed within the knife track.The reload was found to have a firing failure during in-house testing.There was no blade or leadscrew damage observed.There were no logs available at this moment.The complaint regarding the reported issue was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of the reported event is attributed to damage during use.For example: firing across a staple line or other obstructions.Additional observations not related to the reported event and not reported by the customer: the reload was observed to be partially fired.The reload was disassembled in-house and the cartridge appeared to be damaged within the knife track.The damages within the knife track were observed near the location of the exposed component.The probable root cause of this failure is attributed to damage during use.The reload was also found to have tiny metal fragments within the knife track.The metal fragments were found near the exposed component.The probable root cause of this failure could not be established and the stapler 45 blue reload has been transferred to engineering team for further investigation.A follow-up mdr will be submitted after further failure analysis investigation and if additional information is obtained.

Manufacturer Narrative

The stapler 45 blue reload was further investigated by the advanced failure analysis engineer.Review of the logs showed the firing was completed; however, visual inspection confirmed that the blade was exposed while the firing was at approximately 40% completion.Peak fire torque recorded during the firing was 133.1 mnm, which was close to, but still below the fire torque limit.Additionally, inspection found leadscrew was damage to the threads in the fired section of the leadscrew.Metal shavings from the leadscrew were found in the cartridge and on/around the leadscrew and shuttle.There is not a potential for these fragments to fall into the patient, as the reload cover holds the metal shavings within the reload until reload cover is removed.The damage to the leadscrew threads stopped the progress of the shuttle and caused the blade to be exposed.Minor blade damage and skiving damage to the inner walls of the t-slot on the cartridge were also observed, which were likely related to high resistance when firing.Cartridge damage was intertwined with metal shavings; however, no fragments were missing.Generally, when there is leadscrew thread damage present, the logs typically would show the peak firing torque exceeding the fire torque limit.However, in this case the peak fire torque did not exceed the torque limit, which could explain why the system did not trigger an error during the firing.Based on the damage observed on the cartridge, blade edge, and leadscrew, it was likely the user fired across something with a high resistance.Firing across an obstruction or tissue that is too thick is considered mishandling and misuse.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45 RELOAD BLUE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16220434
• MDR Text Key: 308945931
• Report Number: 2955842-2023-10238
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90210906
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48645B-04
• Device Catalogue Number: 48645B
• Device Lot Number: L90210906 0655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES