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

Model Number 380652-50

Device Problem Unintended System Motion (1430)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) contacted the customer to follow-up on the reported issue.The customer noted that the issue did not persist after contacting technical support.The fse checked the system logs and noted that there were no further issues in the logs.The customer also confirmed that there have been no other instances of the issue since the report of the event.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or procedure video was provided for review.A review of the site's system logs for the reported procedure date was conducted by the tse.Investigation revealed the following possible related system errors: 22020|installed mcs (monopolar curved scissors/8x19) failed to engage on usm3 (wrist pitch axis failed to engage).This complaint is considered a reportable malfunction due to the following conclusion: during a procedure, the instrument exhibited unintended movement.Unintuitive motion could lead to subsequent tissue damage.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

The robotics coordinator called an intuitive surgical inc.(isi) technical support engineer (tse) to report that during a case the previous day, the surgeon was working and the instrument moved backwards while they were using it.The robotics coordinator stated that this movement was unintended.The surgeon was able to complete the case, but wanted to have the tse review the logs.Tse noted error 22020 on universal surgical manipulator (usm3) during that timeframe.The robotics coordinator stated that it could have been a drape issue and they will monitor the system to see if the issue occurs again.Customer would like the field service engineer (fse) to follow up after next cases to ensure the issue did not return.The procedure was completed with no reported injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 14067537
• MDR Text Key: 298580586
• Report Number: 2955842-2022-10969
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2022

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: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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