MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LARGE NEEDLE DRIVER

Model Number 470006-12

Device Problem Scratched Material (3020)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the large needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of frayed grip cable at the distal end to be related to the customer reported complaint.The frayed cable strands stuck out at the wrist.The root cause of frayed distal grip cables is attributed to a component failure.An additional observation, which was not reported by the site, was that the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.055¿ - 0.116¿ in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions instrument main tube is typically attributed to mishandling/misuse.A review of the instrument log for the large needle driver instrument (part # 470006-12 /lot# n11200921-0183) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021, on system (b)(4).The instrument had 4 uses remaining after last use.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 video clip for the reported event was submitted for review.This complaint is 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 nipple sparing malignant mastectomy with reconstruction surgical procedure, the large needle driver was found to have a cable cut.A backup instrument of the same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that no fragment fell into the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications.

• Brand Name: ENDOWRIST
• Type of Device: LARGE NEEDLE DRIVER
• 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: 13691437
• MDR Text Key: 296849753
• Report Number: 2955842-2022-10517
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112151
• UDI-Public: (01)00886874112151(10)N11200921
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2022

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: 470006-12
• Device Catalogue Number: 470006
• Device Lot Number: N11200921 0183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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