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

Model Number 380652-40

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received a da vinci product related to the alleged issue.An return material authorization (rma) was not issued for return at this time and no site visit was conducted.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer-reported issue.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the universal surgical manipulators (usm) stopped moving and the table could no longer be coupled.In addition, the error during booting up was noted that day in the morning.The usms must have moved intraoperatively the day before.No known impact or patient consequence was reported.

Manufacturer Narrative

An intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon disabled the usm arm due to an issue, making it unusable.The procedure initially involved all 4 usm arms, but the error message appeared at the end when the usm arm was no longer needed.Subsequent procedures were successfully performed with only 3 usm arms, without any harm to the patient.The patient was not injured during the procedure.The instrument, accessory, and system were inspected prior to use and no damage or abnormalities were found.The failure was not related to an inability to move the instrument.The operation was not delayed due to this problem.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18625631
• MDR Text Key: 334368517
• Report Number: 2955842-2024-10881
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/11/2024

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: 380652-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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