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

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.

• Brand Name: DA VINCI
• Type of Device: TIP 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 Key: 12038561
• MDR Text Key: 257409500
• Report Number: 2955842-2021-10688
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/22/2021
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES