MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LARGE NEEDLE DRIVER

Model Number 471006-12

Device Problem Break (1069)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the large needle driver instrument was found to have broken shaft.A backup instrument of the same type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made follow up attempt to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the large needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis found the primary failure of broken main tube to be related to the customer reported complaint.The instrument was found to have the main tube broken.A piece measuring proximately.138¿ x.161¿ was not returned with the instrument.The root cause is typically attributed to the mishandling / misuse.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.A review of the instrument log for the large needle driver instrument (pn# 471006-12 / lot# n10210222-0126) associated with this event has been performed.Per logs, the instrument was last used on 01/05/2022 on system sl0731 for approximately 16 minutes on the 6th use of the instrument.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: LARGE NEEDLE DRIVER
• 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: 14897159
• MDR Text Key: 301909592
• Report Number: 2955842-2022-12741
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119754
• UDI-Public: (01)00886874119754(10)N10210222
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/01/2022

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
• Device Operator: Health Professional
• Device Model Number: 471006-12
• Device Catalogue Number: 471006
• Device Lot Number: N10210222 0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 07/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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