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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 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
The part #400180-14/lot #m91191108 does not show in the system logs due to the part being an accessory. Therefore, an instrument log review of the product related to the complaint cannot be performed at this time. No image or video clip for the reported event was submitted for review. 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 was noted on the monopolar curved scissors (mcs) tip cover accessory. The split started at the clear part of the accessory and extended to the dark grey area. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the da vinci coordinator and obtained the following additional information: it was confirmed that the issue was identified during the procedure. The mcs tip cover accessory was installed with a tool and without electro-lube. The tear was noted on the clear and the grey area of the accessory. No smoke, sparks or arcing were seen. The surgeon believed that the tear was due to a normal used/unknown cause.
 
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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 Key10131332
MDR Text Key227137189
Report Number2955842-2020-10546
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 05/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
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 NumberM91191108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2020
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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