MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The monopolar curved scissors (mcs) tip cover accessory has been discarded by site, so failure analysis of the tip cover accessory cannot be performed.Therefore, the root cause of the customer reported failure cannot be determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product or this event.No photo or video was provided by the site for review.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.This complaint is being reported due to the following conclusion: the mcs tip cover accessory was damaged due to arcing with no evidence or claim of user mishandling/misuse.In the event the tip cover is compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors 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.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.Blank mdr fields: follow-up was attempted, but the patient information, i.E patient race, ethnicity, relevant tests, results, and patient medical history were not provided.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields in name and address is not available.Fields pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer stated that melting and budding was noted on the monopolar curved scissor (mcs) tip cover accessory.The procedure was completed with no reported injury.Intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the instrument was inspected prior to use and there was no damage or anything out of ordinary.A pin gauge was used to inspect the cannula.A non-removable protrusion (¿like a metal point¿) was observed at the tip of instrument.The arcing issue was observed during dissection with a monopolar coagulation.The monopolar cord was not connected to the bipolar instrument.A conmed generator was used during the surgery.Prior to the arcing event, the instrument was in use for approximately one hour.The site reported that a maryland bipolar forceps and a prograsp forceps instruments were in use when the arcing event occurred.The energy arc was observed from the distal tip and wrist of the monopolar curved scissors instrument.The instrument did not collide with any other instrument or tool during procedure.When the arcing event occurred, the instrument tips were in contact with tissue.While the instrument was energized, the instrument tips did not touch any staples, clips or sutures.Prior to activating the instrument, the jaws were not immersed in liquid or contaminated by carbonized tissue.During the surgery, the instrument was removed and straightened for cleaning prior to arcing issue occurred.The surgeon was not able to provide more information regarding the cause of arcing event.A grounding pad was placed on the patient¿s leg.The grounding pad did not appear to have any issues or defects.The mcs tip cover accessory appeared to be properly installed during the surgical procedure.No part of the orange surface was visible after the mcs tip cover accessory was installed.The mcs tip cover accessory was not installed beyond the orange surface.The installation tool was used.No electrolube or any other lubricant was applied to the mcs instrument prior to the tip cover installation.There were no critical steps observed to the patient.The patient has not returned to hospital in case of any post-surgical complications as a result of the arcing event.The mcs tip cover was destroyed by the hospital and will be not returned to isi for review.

• Brand Name: NONE
• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12943470
• MDR Text Key: 281825981
• Report Number: 2955842-2021-11675
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• 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.
• Patient Sex: Male