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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST TIP COVER ACCESSORY Back to Search Results
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.
 
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Brand NameENDOWRIST
Type of DeviceTIP 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 Key10388568
MDR Text Key241307754
Report Number2955842-2020-10731
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K112263
Number of Events Reported1
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 Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Catalogue Number400180
Device Lot NumberM90190909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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