MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number 380990-16

Device Problems Poor Quality Image (1408); Failure to Calibrate (2440)

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

Event Date 05/05/2022

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 fse was able to reproduce the reported problem.The fse noted that the camera head failed the 3d image calibration.The camera head also had some abnormal sounds while the fse was checking the focus function.The fse reviewed the system logs and found no related error.The fse replaced the camera head to resolve the reported problem.The system was tested and verified as ready for use.Isi has received the camera head for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted following completion of the evaluation.A review of the procedure log showed the site performed this simple prostatectomy surgical procedure on (b)(6) 2022 with system sh2468.The system logs were reviewed/analyzed as part of the fse's investigation.No image or video clip for the reported event was submitted to isi for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.Follow-up was attempted, but the missing 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 simple prostatectomy surgical procedure, the customer called in to report that they could not complete the 3d image calibration, and there was an abnormal sound during the calibration attempt.The customer had rebooted the system twice and tried two back-up endoscopes, but the issue was not resolved.The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer restore to factory settings and perform the 3d image calibration again; however, the issue persisted.The customer gently shook the camera head and did not hear any abnormal sound.At this point, the surgeon then elected to convert to laparoscopic surgery due to the low quality video image from the endoscope.There was no reported injury.On 09-may-2022, isi performed follow-up and obtained the following additional information regarding the reported event: the camera head was inspected prior to use, and a 3d image calibration was performed and failed.It was confirmed that there was no patient harm, injury or adverse outcome.

Manufacturer Narrative

Evaluation was performed on the camera head involved in this event.The customer reported complaint was confirmed.The camera head failed the 3d calibration and had some abnormal sounds when checking the focus function.Additionally, mechanical shock resulted in a damaged stage assembly.The root cause was found to be mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• 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: 14597193
• MDR Text Key: 293737738
• Report Number: 2955842-2022-12012
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110874
• UDI-Public: (01)00886874110874
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081137
• 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: 05/05/2022

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: 380990-16
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 08/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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: Male