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

Model Number 380614-12

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was reproduced during field evaluation.Recoverable soft lock (rsl) errors 816 and 824 were identified upon review of the logs.The patient side cart (psc) battery was replaced, but rsl error 824 was generated when the system was powered on.The auxiliary power board (apb) was replaced, but rsl error 824 persisted.The fse allowed the psc to charge for two hours, and no further errors were noted.The system was tested and verified as ready for use.Intuitive surgical (isi) received the apb for failure analysis investigation on 8-july-2020 and completed the device evaluation.The reported complaint was not reproduced during failure analysis.The unit was installed into the test system.A 10-minute sine cycle and 10 power cycles were performed, and the unit sat idle for one hour.No trouble was found with the unit.Upon visual inspection, the unit was in good condition.Isi received the psc battery on 16-jul-2020 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.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.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 cholecystectomy surgical procedure, error 816 was observed.The customer contacted the field service engineer (fse) for troubleshooting assistance, and the fse had the customer hard power cycle the system, but the issue persisted.The fse determined the patient side cart (psc) needed a battery replacement.The procedure was converted to laparoscopic surgery.There was no reported patient harm, adverse outcome, or injury.Due to the alleged issue, the procedure was delayed by 15 to 30 minutes.Intuitive surgical followed up with the fse to request for clarification on the reported information.The fse confirmed the customer directly contacted the oncall fse when error 816 was occurred for troubleshooting assistance.The customer contacted technical support after the procedure asking service repair arrangements.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: a4, b7, g4, g7, h6 and h10/h11.Corrected information can be found in the following section(s): h10/h11.Additional information: 4307 - intuitive surgical followed up with the customer and obtained the following additional information on 27-july-2020: the customer contacted the field service engineer (fse) for assistance directly prior to converting the procedure.The fse had the customer hard power cycle the system, but the problem still persisted.The fse determined the patient side cart (psc) battery was defective and needed replacement.Then the surgeon made the decision to convert this procedure to laparoscopic.This case was the third planned robotic procedure on that day.The system functionality was checked upon powering on the system before the first robotic procedure; the customer did not power off the system since then.Recoverable soft lock (rsl) error 816 occurred then the customer recovered the fault and continued the procedure.The customer reported the system worked fine in the first two robotic procedures before this case.The customer reported no relevant patient tests were performed specific to the incident and provided the patient's weight.Intuitive surgical received the battery module involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The battery voltages were measured to be 25.10v overall, 13.08v for battery 1 and 12.02v for battery 2.The battery date is (b)(6) 2015.The expected battery pack voltages is 27.60v (2.30 volts/cell) when full and on the float charge.When empty with no charge or load on the battery, the voltage is expected to be 23v (1.93 volts/cell).The battery was installed into the pca system and it failed at startup with error 824, indicating low voltage.The unit failed on the bbm test fixture.Upon visual inspection, the battery was in good condition.Corrected information: in the initial mdr report, the h6 conclusion code "4307 - cause traced to component failure" was submitted in error for the apb fa findings.The correct conclusion code should have been "4310 - cause cannot be traced to device".However, 4307 does apply to the battery module which was most recently analyzed.Based on the additional information provided, this complaint remains reportable 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.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

The battery module was sent to the original equipment manufacturer (oem) to replace the batteries 1 and 2 and gas gauge board.The unit was then inspected and tested to be in full compliance with intuitive surgical, inc.Specification.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10290986
• MDR Text Key: 241925538
• Report Number: 2955842-2020-10656
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2020

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: 380614-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 08/06/2021
• Supplement Dates FDA Received: 08/09/2020; 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 65 YR
• Patient Weight: 65