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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DA VINCI 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 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the customer reported complaint. The tip cover was found to have tearing at the mouth. The tear was axially aligned with the tip cover and measured from 0. 021¿ to 0. 133¿ in length. There were no signs of thermal damage present at the end of any tears. Tears at the mouth are most commonly caused by repeated thermal and mechanical stresses. No log review was performed as instrument log review does not provide any information regarding an mcs tip cover accessory. No image or video clip for the reported event was submitted for review. A complaint history review for the site was performed, and there were no additional complaints related to the product identified. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the mcs tip cover accessory had a tear on the grey part of the accessory, which could lead to arcing. Although no arcing was seen and no patient harm, adverse outcome or injury occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the monopolar curved scissors (mcs) tip cover accessory tore during standard use. Intuitive surgical, inc. (isi) contacted the site and obtained the following additional information regarding this event: the procedure was completed using a backup tip mcs tip cover accessory with no adverse effect or injury to the patient. No fragment fell inside the patient's anatomy. The issue caused a delay of 10 minutes. There was no instrument collision when the issue occurred. The tear is on the distal clear silicone tip.
 
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Brand NameDA VINCI
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 Key10475566
MDR Text Key205498533
Report Number2955842-2020-10845
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2020
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 NumberM90200131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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