MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number 471400-10

Device Problems Break (1069); Fracture (1260)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

It was reported during a da vinci-assisted pulmonary lobectomy procedure, that the instrument broke while inside the patient.There were no fragments that fell inside the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) performed follow-up with the customer and obtained additional information related to the event.The long bipolar grasper instrument was not responding to the surgeon console commands.The instrument got stuck at an angled position and would not come through the trocar.The instrument and trocar had to be removed together.A surgical scrub tech removed the instrument from the trocar while outside of the surgical field.The instrument was inspected and there were no missing pieces noted.The patient has not returned to the hospital due to any post-surgical complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the long bipolar grasper instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was found to have the main tube broken.A piece measuring approximately 0.150¿ x 0.330¿ was not returned with the instrument.The root cause of broken instrument main tube is typically attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the device logs for the long bipolar grasper (part# 471400-10| lot-sequence# k10211004-0012) associated with this event has been performed.Per this review of the logs, the long bipolar grasper was last used on 02/10/2022 during a pulmonary lobectomy on system serial# sk1704.No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged that a fragment had detached/broke off from a portion of the device that enters the patient and was returned.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 and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.Blank mdr fields: follow-up was attempted, but the 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.Field e4 is blank because it is unknown if a report was submitted to the fda by the initial reporter.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• 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: 14138855
• MDR Text Key: 298888092
• Report Number: 2955842-2022-11129
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(10)K10211004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2022

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: 471400-10
• Device Catalogue Number: 471400
• Device Lot Number: K10211004 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: 03/19/2022
• Initial Date FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White