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

Model Number 380652-51

Device Problem Insufficient Information (3190)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the reported injury cannot be determined.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse confirmed that there was no obstruction on the left and/or right cart drives, the battery capacity was okay, and the full cart drive was functioning normally.The drive selection was changed to manual, and the cart could be driven manually, as expected.The full dte cart drive and brake tests were completed successfully.No fault was found.The system was tested and verified as ready for use.Per a review of the site's system logs, there was no indication of any failures that would have likely caused or contributed to the reported complaint.

Event Description

During an internal service activity, the patient side cart (psc) was driving very slowly, and a nurse was injured.The nurse was moving the psc from one operating room to another; at the beginning of the transfer, the psc was moving at a steady speed, which did not require physical effort apart from guidance.The nurse felt that her positioning adjusted as the psc began to move more slowly.She switched to manual movement, and she attempted to manually drive the psc with help from others.However, the nurse sustained an injury to her shoulder which was later diagnosed as a muscle tear.This injury required two weeks of leave due to pain and reduced range of motion, 6-8 weeks of reduced manual handling, and physiotherapy treatment.The customer contacted the technical support engineer (tse) team regarding this incident, and the tse found no issues in the system logs.The tse asked if the psc was properly charged, and the customer confirmed that the battery was fully charged at the start of the transfer, and it was half-charged at the end.The customer requested that the psc be evaluated to verify that the motor drive is fully functional.

• 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: 18753933
• MDR Text Key: 335930885
• Report Number: 2955842-2024-11563
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-51
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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