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

Model Number	420230-09
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the large clip applier instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of the failed clip test to 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 moved intuitively with full range of motion in all directions.The clip test was performed and failed on multiple attempts.Upon visual inspection, the grip tips did not exhibit any damage.The root cause is not determinable/applicable.Failure analysis investigations also found an additional failure related to the customer reported complaint.The instrument was found to have a loose grip cable at the distal idler pulley, likely causing the clip test failure.The housing was removed for inspection and no damage was found.The root cause of this failure is attributed to a component failure.A review of the logs showed the large clip applier instrument (part# 420230-09 / lot# n10180212-337) was last used on (b)(6) 2021 during a procedure with system (b)(4).The large clip applier instrument has 100 allotted uses and had 42 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the large clip applier instrument.No image or video clip for the reported event was submitted to isi for review.This complaint is being reported due to the following conclusion: failure analysis confirmed a failed clip test with the finding of a loose grip cable.Deficiencies in clip application may lead to inadequate hemostasis.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 prior to the start of a da vinci-assisted prostatectomy surgical procedure, the surgeon could not activate the large clip applier instrument.The customer replaced the large clip applier instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.

• 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: 13752697
• Report Number: 2955842-2022-10596
• Device Sequence Number: 4521789
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10180212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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: 420230-09
• Device Catalogue Number: 420230
• Device Lot Number: N10180212 337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2018
• 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