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

Model Number 380652-48

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

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 complaint. The reported complaint was not reproduced during field evaluation. The universal motion controller (umc) was replaced. The system was tested and verified as ready for use. Isi received the umc for failure analysis investigation, however, the investigation is still in progress. Therefore, the root cause of the customer reported failure has not been determined. A follow-up mdr will be submitted to the fda once the failure analysis investigation has been completed and/or if additional information is received. Instrument logs for the system were not available for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure. The procedure was converted to a laparoscopic surgery. Although no patient harm occurred, if this malfunction were to recur, it could likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, error 319 was observed. The nurse restarted the system, but universal surgical manipulators (usm) 2 and 3 were not lit. The procedure was converted to laparoscopic surgery with no reported injury. On 22-december-2020, intuitive surgical, inc. (isi) obtained the following additional information from the customer: the system powered on before port placement. The system functionality was normal, and there were no errors. The customer contacted the isi field service engineer (fse) for troubleshooting assistance at the time when the error occurred, but the issue could not be resolved. The nurse had no information about the patient's current status. Patient demographic information was requested, but the site was unwilling to provide further information. On (b)(6) 2021, the fse confirmed ports were placed on the patient. The operation was not aborted. The operation was converted to laparoscopic surgery.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11188237
• MDR Text Key: 240954735
• Report Number: 2955842-2021-10059
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2020
• 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