MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-08
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during three separate da vinci -assisted low anterior resection procedures on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021, there was a non-intuitive motion issue with the large clip applier.This report will cover the reported incident on (b)(6) 2021.For the procedure on (b)(6) 2021, bleeding of 750 ml was observed from the inferior mesenteric artery (ima).The patient did not receive a blood transfusion and it is unknown if any surgical/medical intervention was required.According to the surgeon, there was uncontrolled movement during application of the clip when closing the jaws.
Additional Manufacturer Narrative
Intuitive surgical, inc (isi) has received the part associated with this complaint and completed investigations.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint ¿non-intuitive motion (fa) on arms/instruments.Visual inspection of the instrument found no physical or cosmetic damage on the distal end or the back end.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly and was able to hold and snap clip during the clip test.The instrument was fully functional.There was no problem detected.A review of the site's complaint history shows (2) additional complaints, were created to capture non-intuitive motion associated with the device on two separate event dates: (b)(6) 2021 and (b)(6) 2021.A review of the instrument logs for the event date of (b)(6) 2021 has been performed by an intuitive surgical, inc.(isi) advanced failure analyst (afa) and the following was observed: the system logs are unable to detect whether unintuitive motion of instrument was experienced by the user since it would not show up as an error.Unintuitive motion is usually caused by a grip or pitch cable being loose or broken.The system logs were also reviewed for possible unintuitive motion of the arms but the logs do not pick up unintuitive motion of the patient side cart arms.There were no sensor errors of the patient side manipulator (psm) seen.Non-intuitive motion would be more likely to be caused by the instrument(s).No image or video clips for the reported event were submitted by the customer for review.This complaint is being reported due to the following conclusion: during a da vinci assisted low anterior resection, there was a report of non-intuitive motion with the large clip applier instrument and report of patient bleeding.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• 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: 14876240
• Report Number: 2955842-2022-12641
• Device Sequence Number: 14869318
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10170704
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 420230-08
• Device Catalogue Number: 420230
• Device Lot Number: N10170704 195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2017
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG