MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the provided image of the mcs tip cover accessory was performed.There was a tear on at the mouth on the clear distal end.The tear did not appear to reach the gray silicone area.There was no missing material observed, and there were no signs of thermal damage present.The provided image was consistent with the reported complaint of "the tip cover is split in the front"; however, the root cause of the failure mode was not confirmed without the returned accessory.Intuitive surgical, inc.(isi) received the mcs tip cover accessory involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The mcs tip cover accessory was found to have tearing at the mouth on the distal end.Tears were axially aligned, measured from 0.204" in length, and reached the gray silicone area.There were no signs of thermal damage present at the end of any tears.No material appeared to be missing.Tears at the mouth are most commonly caused by repeated thermal and mechanical stresses.The root cause of this failure is attributed to a component failure.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 information provided at this time, this complaint is being reported due to the following conclusion: the mcs tip cover accessory had holes/tears/missing material on the gray silicone area with no evidence or claim of user mishandling/misuse.Although there was no patient harm, if this malfunction were to recur it could likely cause or contribute to an adverse event.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date for the expiration date field is not applicable.Field implant date is blank because the product is not implantable.The information for blank fields in initial reporter is not available.Field recall (if recall number is given) is not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the surgeon noticed that the monopolar curved scissors (mcs) tip cover accessory had a split in the front during use.There was no report of fragments falling inside the patient.The procedure was completed with a second mcs tip cover accessory, and there was no reported injury.The customer is unable to release patient demographic information for this event.On 19-january-2021, intuitive surgical, inc.(isi) obtained the following additional information from the customer: the surgical staff did not see any evidence of arcing during the surgical procedure; however they noticed that when the surgeon energized the mcs instrument, the tissue around the "spite" tip cover was affected.No information was provided regarding patient history, pre-existing medical conditions, and tests/laboratory data.

• Brand Name: ENDOWRIST
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11213906
• MDR Text Key: 228166340
• Report Number: 2955842-2021-10071
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)M90200117
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M90200117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES