MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED TIP STAPLER 45

Model Number 470545-05

Device Problems Retraction Problem (1536); Failure to Fire (2610)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the part associated with this complaint and completed device evaluation.Failure analysis investigations confirmed but did not replicate the customer reported complaint.The root cause is not determinable.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument passed initialization.The instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly.The instrument clamped, fired and unclamped without any issues.Additional observations not reported by site that is not related to the customer reported complaint: the instrument was found to have a reload recognition failure based on log review.The root cause is not determinable/applicable.The instrument was found to have the yaw plate broken.Yaw plate web is bent outwards towards the fire cardan.The root cause of broken instrument pivot plate is typically attributed to mishandling/misuse, such as excess force applied to the distal end of the instrument.The instrument was found to have failed the engagement test based on log review.The root cause is not determinable/applicable.System log reviews showed two instances of error 22030 (firing failure/general failure) on the stapler instrument installed on universal surgical manipulator (usm2).A review of the logs for the curved-tip stapler four associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: dsp logs show that pn 470545-05, lot t10210625-0001 was installed 2x and fired two reloads (both white).Each firing resulted in a firing failure (at 17% and 18% completion).There was 1 incomplete clamp on the first install, but no incomplete clamps on the second install.Msc logs confirm the two firing failures via error code 22030 with p1 = 1.No image or video of surgery was provided.This complaint is reportable due to the following conclusion: it was alleged that two firing failures occurred with the curved tip stapler 45.The logs show error 22030, which is a partial fire.The stapling issue occurred on a renal vessel.A third party laparoscopic stapler was used to complete the procedure.At this time, it is unknown what caused the event to occur.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer called an intuitive surgical inc.(isi) technical support engineer (tse) to report the surgeon encountered two stapler firing failures with the curved tip stapler 45.The reporter was uncertain of the messaging that was reported during the firing failures.Tse recommended the customer replace the stapler instrument with a backup and return the original stapler instrument.The surgeon proceeded with the procedure but did not want to use a second stapler instrument.The procedure was completed as planned robotically.On 07-feb-2022, intuitive surgical, inc.(isi) followed up with the robotics coordinator and obtained the following additional information: it was reported that the surgeon was attempting to staple the renal artery or vein when the issue occurred.A message, "incomplete fire", possible blade exposure¿ was obtained.The stapling issue occurred during the first and second fires, with white reloads as a vascular load was required for the vessel.There was no obstruction in the jaws, no buttress material used and no known tissue issue present.There were no malformed staples seen.A laparoscopic stapler was used to continue the procedure.The reload is not available for return.The stapler is in transit to isi.No video/images are available to isi for review.

• Brand Name: ENDOWRIST
• Type of Device: CURVED TIP STAPLER 45
• 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: 14849241
• MDR Text Key: 303259797
• Report Number: 2955842-2022-12526
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/02/2022

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: 470545-05
• Device Catalogue Number: 470545
• Device Lot Number: T10210625-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES