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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
Device Problems Crack (1135); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
The monopolar curved scissors (mcs) tip cover accessory has been scrapped and is not available for investigation purposes. Root cause of the customer reported failure mode was unable to be determined for this alleged issue. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The review of the provided image is consistent with the alleged crack in the mcs tip cover accessory. The mcs tip cover accessory, when used as intended, provides insulation over a section of the endowrist mcs instrument so that radio frequency (rf) energy is only available at the instrument scissor tips. Per the i&a user manual "it is important to exercise caution when using a energized endowrist mcs instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized. " failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns. This complaint is being reported based on the following conclusion: the mcs tip cover accessory had a hole/tear on the gray silicone area with no evidence or claim of user mishandling/misuse. Although no patient harm 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 scissors (mcs) tip cover accessory was found to have a crack on it. The operating room team replaced the mcs tip cover accessory and proceeded with the case. Intuitive surgical (is) requested additional information and obtained the following regarding this event: the mcs tip cover accessory was inspected prior to use and did not collide with any other instrument or tool during procedure. It appeared to be properly installed during the surgical procedure. No fragments fell inside of the patient's anatomy. The procedure was completed with no patient harm, injury or adverse outcome due to the alleged product issue. The issue did not cause any procedure delays. The mcs tip cover accessory has been scrapped and is, therefore, not available for investigation purposes.
 
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Brand NameDA VINCI
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12038561
MDR Text Key257409500
Report Number2955842-2021-10688
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
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 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
Device Catalogue Number400180
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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