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

Model Number 380652-48

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse manipulated the setup joint (suj) 2 and the system faulted with error 40106 and 17.The fse replaced the suj 2 to resolve the reported issue.The system was tested and verified as ready for use.Isi received the inner proximal suj involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the reported complaint, however, confirmed the errors occurred via the system error logs.The inner proximal suj started up in normal mode and went through its full range of motion (rom) with no errors.The suj unit was tested on the patient side cart fixture test platform (pftp) and passed horizontal/vertical brake, horizontal/vertical encoder, and z-twang tests.No visual indications were found that could possibly have contributed to the reported problem.This complaint is being reported due to the davinci system malfunction rendering the davinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if the reported malfunction were to recur, it could cause, or contribute to an adverse event.Site history: a review of the site's complaint history does not reveal any other complaints involving this product.Product and event verification: a log review was conducted, which resulted in the following findings: the logs confirmed a malignant total hysterectomy procedure was performed on (b)(6) 2020 on system sk3605.System log review: a review of the site's system logs for the reported procedure date was conducted by the technical service engineer (tse).Investigation revealed the following possible related system errors: multiple 319 and 40084 errors pointing to the setup joint (suj) 2.Video/image: no image or video clip for the reported event was submitted for review.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer experienced a non-recoverable fault upon starting.The customer informed the technical service engineer (tse) that they had rebooted the system twice with no change.The tse reviewed the logs and found error 319 and 40084 pointing to the setup joint (suj) 2.The tse had the customer power down the system, cycle the patient side cart (psc) breaker, and emergency power off (epo) the psc.It was noted the system powered on with no change.The customer then decided that they would convert to another davinci system.There was no reported injury, or harm.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and technical support manager and obtained the following additional information: the csr reported that the procedure conducted was a malignant hysterectomy.The system was inspected prior to use, and no issues were noted during the system setup.It was stated the customer experienced a non-recoverable fault that could not be fixed intraoperatively with field service engineer (fse) intervention at a later time.It was unknown if there were any outside influences impeding movement of the system, or arms.The surgeon believed the reported issue occurred due to a system failure.It was confirmed that the procedure was converted to another davinci system.Troubleshooting was exhausted and the arm could have been disabled if they did not need the 4th arm.No video/image was available for review.The procedure was completed robotically with the second davinci system with no patient injury, or harm.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10866196
• MDR Text Key: 219511958
• Report Number: 2955842-2020-11225
• 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: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/27/2020

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: 380652-48
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2020
• 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