MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA SUTURECUT ND

Model Number 471309-15

Device Problem Break (1069)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the mega suturecut needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the reported complaint.Failure analysis found the primary failure of jaw broken off to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.21" x 0.12" was found to be broken off the wrist assembly.The broken piece was not returned.The root cause is attributed to mishandling/misuse, such as excess force applied to the instrument jaw.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.A review of the instrument log for the mega suturecut needle driver (part# 471309-15 / lot# k10211101/ sequence# 0230) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 14 uses remaining.Based on this review, the instrument was not used in subsequent procedure(s) after the alleged event.This complaint is considered 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.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 incisional hernia procedure, the mega suturecut needle driver's jaw broke off when the instrument was taken out of the cannula.A piece fell off on table.There was no report of fragment fell into the patient.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: MEGA SUTURECUT ND
• 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: 13980591
• MDR Text Key: 298164353
• Report Number: 2955842-2022-10845
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119815
• UDI-Public: (01)00886874119815(10)K10211101
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471309-15
• Device Catalogue Number: 471309
• Device Lot Number: K10211101 0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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