MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-03
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional 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 could not reproduce the reported issue that endoscopic camera manipulator (ecm) being stuck.However, the fse confirmed that the bearing of the ecm in-out movement had fallen off, which could contribute to the cause of the reported issue.The fse replaced the ecm to resolve the issue.The system was tested and verified as ready for use.The ecm unit involved with this complaint has been returned for evaluation.Failure analysis was able to reproduce the reported complaint during test driving.The lead screw assembly will be replaced as a fix.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: during a da vinci-assisted surgical procedure, the endoscopic camera manipulator (ecm) movement was stuck on the vertical axis and did not improve despite troubleshooting.The procedure was converted to open and completed successfully.The patient had increased procedure time and enlarged incision lines due to the conversion.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy (radical extraperitoneal without lymphadenectomy) surgical procedure, the customer informed the technical support engineer (tse) that endoscopic camera manipulator (ecm) movement was stuck about an hour after the surgery started.The ecm issue occurred on the vertical axis, which could not be moved up and down.The other patient side manipulators (psms) were normal.The tse reviewed the error logs but could not find any related errors.The tse had the customer perform hard power cycle and replace the drape, but the issue persisted.The surgeon elected to convert to open surgery.The procedure was completed successfully.The customer stated that there was patient injury because the incision site was extended and prolonged procedure time.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
On 11/30/2022, the following additional information was obtained: the system functionality was checked upon powering on the system without errors.The patient tolerated the open procedure well.The patient's hospitalization was prolonged due to the procedure conversion.It was unknown if the patient experienced any post-operative complications following the surgical procedure.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 15866762
• Report Number: 2955842-2022-15529
• Device Sequence Number: 2532218
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380686-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/25/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male