MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; HARMONIC ACE

Model Number	420275-03
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the cause of the operative complication cannot be determined.A follow-up mdr will be submitted if additional information is obtained.Review of the system log was completed and no related system errors were observed.The system logs did not have any errors that indicated fault with the system.However, this procedure did contain errors indicating ¿drift¿ during following caused by the surgeon not having their hand on the master tool manipulator (mtm).These errors cannot be directly attributed to the event that occurred.The complaint mentioned that the event occurred 20 minutes before the end of the procedure.No errors line up with the timing of the event based on a review of the logs this complaint is being reported due to the following conclusion: during a da vinci-assisted total gastrectomy procedure, the patient experienced a splenic arterial rupture.The issue occurred when the surgeon experienced intermittent non-intuitive motion of usm #1 with a harmonic ace curved shears instrument installed.As a result, the surgeon made the clinical decision to convert to open surgery.The cause of the operative complication is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted total gastrectomy procedure, the patient experienced a splenic arterial rupture.The issue occurred when patient side manipulator (psm) #1 installed with harmonic ace curved shears instrument experienced intermittent non-intuitive motion 20 minutes before the end of the procedure.The psm could not move normally.The cause of the bleeding could not be identified but was reportedly an unexpected part of the procedure.The bleeding is not believed to be related to a da vinci instrument or accessory.The hospital thinks the complication had nothing to do with the an intuitive surgical, inc.(isi) device and therefore, no products are expected for return for evaluation.The patient¿s current status is unknown.The surgeon¿s head was inside the high resolution stereo viewer (hrsv) of the surgeon side console (ssc) when the event occurred.Additionally, the issue occurred while the surgeon was attempting to manipulate instruments from the ssc.The failure was not related to an inability to move the instrument at all.The timing of the instrument movement was reportedly not appropriate.However, it is unknown whether the movements of the surgeon scaled appropriately to the instrument or whether the instrument moved in a unintended direction.There was no shakiness or friction experienced or observed.There was no instrument-to-instrument or system arm-to-arm interference.There were no external collisions.The harmonic ace curved shears instrument was inspected prior to use and no damage was observed.The instrument is not available for return.No action was taken to resolve this issue and the same system was used in a second procedure that day with no observed issues.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
This report captures the harmonic ace instrument used in the procedure.A separate medwatch report with mfr report number 2955842-2023-11856 was submitted for the patient side cart (psc) patient side manipulator (psm).Section d10 - the customer reported that there was one event with one harmonic ace instrument, however, two were used during the procedure and the customer did not know which one was installed on the psm during the event.The second device product information is: harmonic ace product number 420275-03, lot number n10210512-224.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: HARMONIC ACE
• 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: 16699086
• Report Number: 2955842-2023-11826
• Device Sequence Number: 5772837
• Product Code: NAY
• UDI-Device Identifier: 00886874111765
• UDI-Public: (01)00886874111765(10)N10191125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 420275-03
• Device Catalogue Number: 420275
• Device Lot Number: N10191125 284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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: Unknown