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

Model Number	420230-11
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the large hem-o-lok clip applier involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary finding of failed intuitive motion be related to the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument failed to move intuitively with full range of motion in all directions on several attempts.The grips did not open and close properly.The instrument was not fully function and did not followed the master tool manipulator commands smoothly.The root cause is not determinable.No image or video clip for the reported event was available for review.A system log review was performed, but no errors related to this event would exist in the logs.A review of the device logs for the large clip applier (part # 420230-11, lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the large clip applier was last used on (b)(6) 2022 via system serial # (b)(4) for a radical prostatectomy with lymphadenectomy surgical procedure.There were 85 uses remaining after this last usage.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.This complaint is considered a reportable malfunction due to the following conclusion: failure analysis confirmed the clip applier instrument moved with unintuitive motion (e.G.The instrument unexpectedly jerked/jumped/swung/bowed, moved in an unexpected/unintended/unknown way).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.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the large hem-o-lok clip applier instrument had non-intuitive motion.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the nurse and obtained the following additional information: the instrument was inspected prior to use and no issue was found.The movement of the instrument was not smooth and unintuitively.The issue was solved using back up instrument.Each occurrence was with the same instrument on the same system arm.The drape was not exchanged at any time during the procedure.The drape was already disposed.No photographic images of the device(s) or a video recording of the procedure available for isi review.

• 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: 14898703
• Report Number: 2955842-2022-12762
• Device Sequence Number: 12059487
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10210802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050369
• 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
• Report Date (Section B): 06/02/2022

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: 420230-11
• Device Catalogue Number: 420230
• Device Lot Number: N10210802 884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 07/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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