MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-29

Device Problem Output Problem (3005)

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

Event Date 12/22/2023

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 event.The fse replaced the integrated electrosurgical generator unit (iesu) to resolve the issue.The system was tested and verified as ready for use.Isi has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, monopolar energy was not firing and the integrated electrosurgical generator unit (iesu) was giving error c-34.Prior to calling intuitive surgical, inc.(isi) technical support, the customer had restarted the iesu, replaced twice the monopolar cautery cable, replaced the instrument and tried another port on the iesu, but the issue was not resolved.The isi technical support engineer (tse) reviewed the live logs and identified errors c-34 pointing to a low voltage issue.The caller confirmed that there was no source of magnetic interference nearby.The tse asked the caller if the iesu was connected to a dedicated alternating current (ac) outlet.The caller stated that they had already tried another wall power socket, but the issue persisted.The tse explained that the faulty iesu needed to be replaced.The surgeon agreed to continue with using only bipolar energy.The procedure was resuming as planned with no reported injury.

Manufacturer Narrative

An intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The integrated electrosurgical unit (iesu/erbe) was analyzed and failure analysis investigation confirmed and reproduced the customer reported complaint.The iesu was placed on an in-house system and was run in normal mode.The iesu has no significant scratches or dents.The front bezel is not cracked.The iesu is in good condition.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 18529313
• MDR Text Key: 333503904
• Report Number: 2955842-2024-10395
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• 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,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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 Sex: Male