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

Model Number	380675-04
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting an inverted motion on the psm 3, an investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The isi fse worked with the customer and continued the case.The fse checked the system and noticed that the set up joint (suj)x axis 5 brake was broken, and the arm can rotate more than expected.The fse completed the calibration of sjx and explained to customers the issue and how to dock the arm correctly to continue cases.The fse then replaced the suj to resolve the issue.The system was tested and verified as ready for use.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer-reported issue.The product has not been returned for evaluation.Therefore, the root cause of the customer-reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.This complaint is considered as a reportable malfunction due to the following conclusion: it was alleged that the psm 3 moved with a non-intuitive motion.Unintuitive motion could lead to subsequent tissue damage.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.
Event or Problem Description
It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the surgeon notices patient side manipulator (psm) 3 (psm) flips when switching between psm 2 and 3.The caller repositioned the setup joint, ensured the masters were properly configured, and performed a hard power cycle.The caller indicated there's a strange friction on the fourth usm when moving it and it seems to rotate further than normal.All troubleshooting options were exhausted when trying to get the psm to respond normally on the left side (switching between arms 2/3).The caller switched the set up joint (suj) to the right side (switching between psm 1/3).The master still flipped on the right side and the motion was non-intuitive.The caller ended the call.Isi followed up with the isi field service engineer and obtained clarification: the customer reported that the psm 3 on si system was having non-intuitive motion.The surgeon reported that it went left when he moved the arm to the right from the surgeon side console (ssc).The axis 5 joint on the psm 3 was broken, meaning the joint¿s rotation was over normal.The system has the camera arm, arm 1, arm 2, and arm 3.The set-up joint was ordered for arm 3 replacement.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The set up joint (suj) was analyzed and the reported failure was confirmed.It was found the suj had restricted movement at axis 5.This type of error did not show up on error log history.The stop block wrist was found broken.The suj was not repairable and would be scrapped.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM, 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: 16881740
• Report Number: 2955842-2023-12406
• Device Sequence Number: 14910531
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 380675-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 10/27/2023
• 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