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

Model Number 380652-50

Device Problem No Device Output (1435)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) confirmed with the customer that there were no issues on the following case.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.A review of the system logs was performed.Per the review, the following was confirmed: system sk4260, event date (b)(6) 2022 and procedure name - inguinal hernia.Furthermore, a review of the site's system logs for the reported procedure date was conducted by technical support.Investigation revealed the following possible related system errors: 31010|sterile adaptor sensor missing on usm3.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: a usm was abandoned 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 reported failure mode could likely cause or contribute to an adverse event if it were to recur.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.Blank mdr fields: follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted inguinal hernia surgical procedure, arm 3 stopped working, technical support was contacted and the technical service engineer (tse) was informed by the customer that the surgeon could not take control of arm 3.Prior to the call, the customer stated that they moved the instrument to arm 4 and completed the case.The tse asked if the surgeon might have hit the arm swap pedal at the surgeon side cart (ssc), which would have changed the master tool manipulator (mtm) association from arm 3 (instrument installed) to arm 4 (no instrument installed) the customer was not sure.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and patient demographic information was requested, but not provided.

• 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: 14254305
• MDR Text Key: 299381703
• Report Number: 2955842-2022-11341
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.