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

Model Number 381121-19

Device Problem Output Problem (3005)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse identified errors u-02 and replaced the iesu to resolve the issue.The system was tested and verified as ready for use.Isi did receive the iesu involved with this complaint to perform failure analysis.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.On startup, the iesu displayed error u-02 and there were various firmware/software installations missing.Upon visual inspection, the iesu showed to have an improperly placed bezel that was not snapped into its place correctly.Otherwise, the iesu is in good condition.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the system was getting intermittent errors on the erbe integrated electrosurgical unit (iesu) while the customer attempted to use both monopolar and bipolar instruments.Prior to calling technical support, the customer tried different instruments, energy cables, and reported the iesu was working better but was concerned the issue may return.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and found several errors c-01 indicating a problem with the cpu and checkmaster.The tse recommended using a backup generator or another da vinci vision side cart (vsc) if possible.The customer was not sure if they had a backup generator or activation cable, and the other da vinci vision towers were in use.The customer called back to inquire if they could use the vessel sealer (vs) instrument with the force triad iesu.The tse informed the customer that they could not as it was not compatible with the bipolar port.The procedure was completed with no reports of patient injury.

• 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: 18946758
• MDR Text Key: 338207343
• Report Number: 2955842-2024-12587
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-19
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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: Female