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

Model Number 400180-14

Device Problem Crack (1135)

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

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical received the monopolar curved scissor (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 and through the entire length of the tip cover. The distal silicone tip was found completely torn off and detached. There are no signs of thermal damage present at the end of any tears. No missing material was observed. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A system log review was not performed for the reported product as the da vinci system does not capture usage history for an mcs tip cover accessory. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: the mcs tip cover accessory was damaged due to arcing and/or 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.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, a tear was observed on the tip cover "under normal daily practice". The procedure was completed with no reported patient harm, adverse outcome, or injury. Due to the alleged issue, the procedure was delayed by 10 minutes. The customer was unable to provide patient demographic information. Intuitive surgical followed up with the customer and obtained the following additional information: there was no damage noted prior to use. The customer indicated that the distal clear tip was damaged. The surgeon does not know what caused the tear. There was no report of collision with an instrument or tool during procedure. Np photographic images of the device(s) or a video recording of the procedure was available. No information pertaining to relevant tests/laboratory data specific to the incident was available.

• 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: 10388568
• MDR Text Key: 241307754
• Report Number: 2955842-2020-10731
• Device Sequence Number: 1
• Product Code: NAY
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M90190909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage