MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-40

Device Problem Material Separation (1562)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that prior to the start of a da vinci-assisted bilateral inguinal hernia repair, but following anesthesia and port placement, a round joint cover on arm 3 of the system was missing.The customer was not able to locate the cover and requested that the field service engineer (fse) follow up to replace it.The procedure was continuing.Intuitive surgical, inc.(isi) performed follow-up and obtained additional information.During the procedure, the surgeon reportedly considered the arm "broken" and opted to not use the arm.The other surgical staff was not aware of any issues with the arm other than the cosmetic cover being missing.The procedure was completed and there was no report of patient injury.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to follow-up with the customer regarding the reported complaint.The fse ordered the replacement part and guided the clinical sales representative (csr) through installing it.No other issues were identified and the system was verified to be operating as intended.The customer had reported that the "robot is broken', however, follow-up from the fse confirmed the system remained fully functional.Motion and power were reportedly fine and working as they should.There was no confirmation at the time of the issue that the arm was in an operable state on the system to be used by the surgeon.The affected part was not able to be located and will not be returned to isi for further investigation.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.No image or video was provided for review.This event is considered to be reportable based on the following information.The universal surgical manipulator (usm) was considered "broken" after the start of the procedure, and the surgeon indicated the robotic arm could not be used at that time.The fse later confirmed the system was functional, but it was unknown whether the arm was down on the system at the time, and why the surgeon considered the arm to be unusable.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.System unavailability after the start of a surgical procedure could lead to the procedure being converted/aborted and may lead to an injury due to the patient's inability to tolerate the procedure change.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13658320
• MDR Text Key: 296710404
• Report Number: 2955842-2022-10443
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-40
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES