MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CADIERE FORCEPS

Model Number 471049-08

Device Problem Break (1069)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the customer reported complaint.Failure analysis found the primary failure of the main tube broken to be related to the customer reported complaint.The cadiere forceps instrument was found to have a broken main tube at the distal end and piece measuring approximately 0.441¿ x 0.470¿ was not returned with the instrument.The instrument was found to have all grip cables and pitch cables broken at the distal end.The pitch cable is a new design an the crimp is not readily visible during failure analysis.From engineering review, the crimp will not fall out unless the grip assembly is severely damaged.There is no material missing.The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of broken grip and pitch cable is attributed to a component failure.As a result of the main tube and cable damage, the entire distal wrist was returned completely dislodged from the instrument.Upon further inspection, the cadiere forceps instrument was found to have mechanically indentations/burrs at the grip tips, distal clevis, and proximal clevis.The root cause of the mechanical indentations/burrs is typically attribute to mishandling/misuse, such as collisions with other instruments or sharp object.Additional observation(s) not reported by site was also identified: the cadiere forceps instrument housing was removed for inspection and the instrument was found to have a dislodged flush tube guide.The backend idler pulleys and idler pulley shaft were all found to be completely dislodged from the upper chassis and loose within the housing.The root cause of dislodged flush tube, idler pulley, and pulley shaft is typically attributed to mishandling/ misuse.A review of the instrument log for the cadiere forceps instrument (471049-08/k102111170375) associated with this event has been performed.Per logs, the cadiere forceps instrument was last used in a procedure on (b)(6) 2022 on system (b)(4).The alleged instrument had 13 uses remaining after the last procedural use.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the procedure was provided for review.This complaint is being reported based on the customer reported complaint.The cadiere forceps instrument reportedly stuck in the cannula.Failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.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.

Event Description

It was reported during a da vinci-assisted esophagectomy- transthoracic- chest anastomosis surgical procedure, the 8mm cadiere forceps instrument was stuck in the cannula.The procedure was completed as planned with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) advance failure analysis (afa) received the 8mm cadiere forceps instrument involved with this complaint and completed the additional device evaluation.Failure analysis investigations confirmed all primary failure analysis.The severe damage to the cadiere forceps instrument was likely due to the mishandling /misuse while breaking the instrument in order to remove it from the cannula.There are no more tests that could be conducted due to the nature of the damage.

• Brand Name: ENDOWRIST
• Type of Device: CADIERE FORCEPS
• 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: 13694369
• MDR Text Key: 296848386
• Report Number: 2955842-2022-10525
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119778
• UDI-Public: (01)00886874119778(10)K10211117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• 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,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471049-08
• Device Catalogue Number: 471049
• Device Lot Number: K10211117 0375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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