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

Model Number 470327-12

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier instrument had a recognition failure and unintended movement on universal surgical manipulator (usm) 3.The procedure was completed with the same medium-large clip applier instrument with no reported injury.On 08-dec-2021, intuitive surgical, inc.(isi) obtained the following additional information from the surgeon regarding the reported event: the medium-large clip applier instrument was responsive, but non-intuitive motion was observed at the wrist of the instrument.The surgical staff resolved the reported non-intuitive motion issue by reinstalling the instrument arm drape on usm 3 and reseating the same medium-large clip applier instrument.In addition, after the surgical staff replaced the clip, the medium-large clip applier instrument was not recognized several times.The surgical staff reseated the instrument arm drape to resolve the reported recognition issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the medium-large clip applier instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.A review of the logs showed the medium-large clip applier instrument (part# 470327-12 / lot# n10210308-0062) was last used on (b)(6) 2021 during a procedure with system sk3330.The medium-large clip applier instrument has 100 allotted uses and had 43 uses remaining.Based on this review, the medium-large clip applier instrument was used in a subsequent procedure after the alleged event reported on this record.In addition, a review of the site's complaint history identified no other complaints related to the medium-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: it was alleged that the medium-large 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.

• Brand Name: ENDOWRIST
• Type of Device: 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: 13085603
• MDR Text Key: 286873490
• Report Number: 2955842-2021-11813
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)210304(10)N10210308
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: N10210308 0062
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES