MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY SPATULA

Model Number 470184-13

Device Problem Fracture (1260)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery spatula associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue as the instrument was found to have both ears of the distal clevis broken.The broken pieces were not returned, measuring roughly 0.169¿ x 0.244¿ in size.No functional test could be performed on an in-house system due to the instrument being unable to properly feed through the camera.An electrical continuity test was performed and passed.Fa noted the root cause of the reported issue is due to the user applying excess force to the instrument tip.A log review was performed.Per the review, the following was confirmed: system serial - (b)(4), event date - (b)(6) 2022, and procedure name - pleural decortication.Additionally, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the additional information obtained from failure analysis investigations, this complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged 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 that during a da vinci-assisted surgical procedure, the instrument tip was broken.The instrument was replaced and the procedure was completed as planned with no report of patient harm, adverse outcome or injury.The permanent cautery spatula (pcs) is intended to be used with the da vinci system for precise dissection and division of tissue with monopolar cautery.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• 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: 14132073
• MDR Text Key: 298876392
• Report Number: 2955842-2022-11101
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(11)210805(10)N10210809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-13
• Device Catalogue Number: 470184
• Device Lot Number: N10210809 0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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