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

Model Number 380620-42

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/02/2021

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.To correct the issue, fse replaced the card cage, the front wheel and the cart brake cable on the patient side cart.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) has not yet received the replaced components for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the products are returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or procedure video was provided.Technical support engineer (tse) reviewed the system logs at the time of the call into technical support.The logs confirmed the reported errors.This complaint is being reported based on the following conclusion: system unavailability after start of a surgical procedure caused the procedure to be either converted or aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion or abortion.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted rectocele repair procedure, a non-recoverable error 865 occurred.The intuitive surgical inc.(isi) technical support engineer (tse) reviewed the system logs and confirmed this error.Tse instructed the caller to power cycle the system and press the emergency power off (epo) button and circuit breaker from the patient side cart (psc), and set the shift switches to n.After doing so, the system was rebooted; however, the error reoccurred.The surgical staff performed a second reboot without success.The tse informed the surgical staff that the system could not be used and that they would need to remove the instruments by hand using the instrument release kit (irk).It is not known if the procedure was converted to open or laparoscopic surgery.There was no patient harm, adverse outcome, or injury reported.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h3.Evaluation information can be found in the following fields: h6 and h10.D14-intuitive surgical, inc.(isi) has received the cardcage associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the reported complaint of an error 865.When the cardcage was installed and tested on an in-house test system, the system started up without any error.The system ran through 150 power cycles and all passed.The cardcage remained on the test system for 7 days in normal operation, and it performed without any anomalies.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI X
• 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: 13082023
• MDR Text Key: 286735327
• Report Number: 2955842-2021-11803
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380620-42
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2021
• 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