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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 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
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 mcs tip cover accessory was found to have tearing at the mouth at the distal end. The tear extended into the gray part as well as the clear distal end. The tear was axially aligned with the mcs tip cover accessory and measured approximately 0. 227 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 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, an 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 there was 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 surgical procedure, the monopolar curved scissor (mcs) tip cover accessory was noted to have a tear. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: it was noted that the issue was identified during procedure, which was completed using a backup mcs tip cover accessory with no adverse effect or injury to the patient. The tear was noted to be on the distal clear silicone tip. There was no instrument collision when the issue occurred. No fragment fell into the patient's anatomy. The issue caused a procedure delay of 10 minutes.
 
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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 Key10396642
MDR Text Key243723247
Report Number2955842-2020-10739
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
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 NumberM91191205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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