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

Model Number 380652-32

Device Problem Insufficient Information (3190)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced universal surgical manipulator (usm) 1 due to it not recognizing instruments.System tested and verified as ready for use.Based on the field evaluation, this reported event was confirmed which indicates that the device may have contributed to the customer reported issue.Isi has received the usm involved with this complaint; however, failure analysis has not completed their investigation.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, there was an unspecified issue with one of the universal surgical manipulators (usm).While on call with the intuitive surgical inc.(isi) technical support engineer (tse), the customer was powering on the system and "da vinci is ready" was heard.The tse viewed the system logs and did not note any associated errors.The customer was unable to provide additional information.The procedure was completed with no reports of patient injury.Isi has made a follow-up attempt to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Failure analysis (fa) has completed their investigation on the universal surgical manipulator (usm).Fa was able to confirm the error via system logs but could not reproduce the issue.The unit was tested on an in-house system and passed normal mode and successfully recognized and engaged instruments.The unit also passed other related tests.

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: 17655776
• MDR Text Key: 322501664
• Report Number: 2955842-2023-18116
• 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,Followup
• Report Date: 08/11/2023

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: 380652-32
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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