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

Model Number 380220-02

Device Problem Unintended System Motion (1430)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci assisted surgical procedure, the arm failed completely.The customer completed the procedure using 3 arms.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 18th-march-2022: the customer stated that the reported arm issue was known.The arm was slightly unstable when moved manually, not when it was moved via surgeon console.The system initially powered on without errors.There was a procedure delay of 15 minutes and the patient was already being warmed.The patient's core temperature was maintained during the delay.There was no patient injury.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the patient side manipulator (psm) #2 to resolve the issue.The system was tested and verified as ready for use.Isi has received the psm involved with this complaint and completed the device evaluation.The customer reported complaint was confirmed by visual inspection.The rear linear bearings and related components will be replaced.The root cause of the issue was attributed to a component failure.The following additional findings were identified during the evaluation: the 8 rear linear screws and 16 belleville washers will be replaced to accommodate rear linear bearings repair.During evaluation, it was observed that the axis 3 mechanical cables have become derailed and the axis 3 mechanical cables will be replaced.The link 3 ground straps were found to be bent during evaluation, therefore will be replaced.The j19 and j20 ffc's will also be replaced to accommodate the repair.The link 4 upper pulley assembly was found to be chipped during evaluation.The link 4 upper pulley assembly will be replaced.The link 4 front lower cover was found to be dented during evaluation.The link 4 front lower cover will be replaced.During evaluation, the link 5 upper pulley assembly was found to have pulley de-coupled from its bearing, therefore will be replaced.The link 5 lower pulley assembly was found to be chipped during evaluation, therefore will be replaced.Rolling loop assembly components will also be replaced to accommodate the repair.During evaluation, damage was found to the ffc's within the link 5 rolling loop assembly.The link 5 rolling loop assembly will be replaced.The link 5 rear cover was found to be scratched during evaluation.The link 5 rear cover will be replaced.The axis 4 mechanical cables were found to be derailed during evaluation.The axis 4 mechanical cables will be replaced.The axis 5 mechanical cables were found to be derailed during evaluation.The axis 5 mechanical cables will be replaced.The axis 6 mechanical cables will be replaced as they were found to be derailed during evaluation.The axis 7 mechanical cables were found to be derailed during evaluation.The axis 7 mechanical cables will be replaced.The link 6 release lever body was found to be cracked during evaluation.The link 6 release lever body will be replaced.There was at least one cosmetic defect found during evaluation.This complaint is a reportable malfunction event due to the following conclusion: an usm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.While there was no harm or injury to the patient, the system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

• Brand Name: DAVINCI SI
• 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: 14109007
• MDR Text Key: 298720865
• Report Number: 2955842-2022-11031
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 0886874110720
• UDI-Public: (01)0886874110720
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2022

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: 380220-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/13/2022
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 67 YR
• Patient Sex: Male