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

Model Number	420327-07
Medical Device Problem Codes	Difficult to Open or Close (2921); Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier (mlca) instrument could not clip due to poor engagement issue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the mlca was inspected visually with no anomaly or damage.The issue occurred inside the patient¿s anatomy.The mlca was able to retain the clip, but it failed to apply the clip.After the failure, the surgeon tried to remove the clip, but the clip was caught to the tissue and fell into the patient anatomy.Eventually, the clip could be retrieved in the same procedure.There was no patient¿s injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the medium-large clip applier involved with this complaint and completed the device evaluation.Failure analysis did not replicate nor confirm the 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 three times and passed.Additional observation, which was not reported by site and was not related to the customer reported complaint, was that the clip applier instrument was found with both grips bent.The instrument had a side-to-side offset of 0.024".The root cause of this failure was typically attributed to the mishandling or misuse, such as applying excessive force to the grips during clip installation.A review of the device logs for the medium-large clip applier (part# 420327-07, lot/serial# k10211101 - 842) associated with this event has been performed.Per this review of the logs, the medium-large clip applier was last used on (b)(6) 2022 via system serial# (b)(4).There were 88 uses remaining after this last usage.No image or video clip for the reported event was submitted for review.This complaint is being reported based on the following conclusion: per the description of the complaint, the clip applier may have incurred a failure mode that is known to impact clip application effectiveness.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.In addition, it was alleged that the clip fell inside the patient during a da vinci assisted procedure due to clip misapplication.The clip was retrieved during the same procedure with no patient injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEDIUM-LARGE 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: 15515202
• Report Number: 2955842-2022-14287
• Device Sequence Number: 5070272
• Product Code: NAY
• UDI-Device Identifier: 00886874111826
• UDI-Public: (01)00886874111826(10)K10211101
• 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): 08/30/2022

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: 420327-07
• Device Catalogue Number: 420327
• Device Lot Number: K10211101 842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: Unknown