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

Model Number	470309-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rma has been returned and evaluated by the failure analysis (fa) team.Intuitive surgical, inc.(isi) received the mega suturecut needle driver (pn: 470309-15 || ln: n12191887 0057 || sn: (b)(4)) involved with this complaint and completed the device evaluation.Fa concluded that the reported failure was confirmed and replicated.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.Additional findings during device evaluation, not reported by the site, and not related to the reportable finding: there were signs of corrosion found on the instrument bearings.Grip and roll input disk bearings exhibit orange discoloration.Improper cleaning during reprocessing most commonly causes this failure.The instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.This failure is most commonly caused by improper reprocessing, such as insufficient flushing.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue; logged events were observed as being in line with normal system functionality: all procedures on (b)(6) 2020; all systems.No image or video clip for the reported event was submitted for review.Site history review was conducted and no additional complaints related to this event were identified.Based on the information provided at this time, this complaint is a reportable event due to the following conclusion: the mega suturecut needle driver instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.The instrument & accessory user manual states: ¿always have a backup instrument available to complete the surgical procedure in case of instrument failure.¿ although there was no report of patient injury related to this event, if this failure were to recur, it could result in an adverse event.Follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a mega suturecut needle driver instrument had a broken wire.The procedure was completed with use of a backup instrument with no reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Refer to the following field for corrected information: d4 - model number.Refer to the following fields for updated information: g3, g6, h2, and h10.The product's model number has been updated to provided corrected information.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10135586
• Report Number: 2955842-2020-10551
• Device Sequence Number: 3853050
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N12191007
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N12191887 0057
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES