MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number 380601-40

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted thyroidectomy surgical procedure, the customer noticed the front arm clutch button was stuck down when pressing the button.The customer had to pull the button out manually and confirmed that there was no errors or issue using the system.The procedure was coontinuing as planned with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on and the system initially powered on without errors.The customer was able to continue the procedure with all 4 arms.No arm was disabled/stowed.Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The customer reported that the front arm clutch button of the entry guide manipulator (egm) got stuck intermittently.The fse checked the egm arm clutch button movement and found the issue persisted.The issue was resolved after replacement of the egm handle (halo handle).The system was tested operated without error and verified as ready for use.Intuitive surgical, inc.(isi) has received the halo handle involved with this complaint and completed the device evaluation.The failure analysis investigation replicated the customer reported complaint ¿the clutch button getting stuck intermittently.¿ the switch only sticks when applying pressure to one side of the button.Abrasion marks were found on the same end of the switch.The halo handle was disassembled, and the switch assembly was found to be mechanically shifted to one side causing the sticking.The root cause was determined to be a component failure.No video clip for the reported event was submitted for review.A review of the procedure log showed the site performed this thyroidectomy surgical procedure on 01-sept-2022 via system serial# (b)(4).Based on the information provided at this time, this complaint is being reported due to the following conclusion: the front arm clutch button of the entry guide manipulator (egm) got stuck, and the customer had to pull the button out manually.The fse confirmed and replaced the halo handle to resolve the issue.System unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.

• Brand Name: DA VINCI SP
• Type of Device: PATIENT SIDE CART
• 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: 15526090
• MDR Text Key: 306416156
• Report Number: 2955842-2022-14330
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/01/2022

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: 380601-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• 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