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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 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the mcs tip cover accessory involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the customer reported complaint of "clear plastic split and started splitting into the dark grey plastic". The mcs tip cover accessory was found to have tearing at the distal end. The tear was axially aligned with the mcs tip cover accessory, measured 0. 205" in length and reached into the grey silicon area. Tears at the mouth are most commonly used by repeated thermal and mechanical stress. Part #400180-14/lot #m91191111, mcs tip cover accessory, does no show in the logs due to the part being an accessory. Therefore, an accessory log review of the product related to the complaint cannot be performed. No image or video clip for the reported event was submitted for review. No other complaints related to this event have been reported. 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 surgical procedure, a split starting from the clear end and extending into the dark grey area of the monopolar curved scissors (mcs) tip cover accessory was noted. The site was completing the procedure with no reported injury. Intuitive surgical, inc. (isi) followed up with the da vinci coordinator at the site and obtained the following additional information: the accessory was inspected prior to use and was appropriately installed without electrolube. No smoke, sparks or arcing was seen during the case. The surgeon believed that the cause of the mcs tip cover accessory tearing was due to normal use. No pictures or videos were available for further review. There was no patient information available.
 
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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 Key10215383
MDR Text Key231303871
Report Number2955842-2020-10616
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
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 NumberM91191111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2019
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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