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

Model Number 400180-08

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors tip cover accessory fell off into the patient during the surgical procedure.The surgeon had to go back in the patient and look for the retained accessory, which was retrieved.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted the surgeon retrieved item and patient safely closed.The procedure delay was for 60-90 minutes.The instrument was inspected prior to use.The surgeon continually was crossing cautery and graspers while in the abdomen (sword fighting).The mcs tip cover accessory was retrieved by lap.Site is unsure if this fell off when removing the item and also unsure of what the surgeon believed caused the accessory to slip off or break.The monopolar curved scissors (mcs) instrument was in use for 6-7hours.The surgeon did not notice any issues with the functionality of the mcs instrument during the surgical procedure.The instrument did collide with other instruments during the surgical procedure.The mcs tip cover accessory appeared to be properly installed during the surgical procedure.It is unsure if part of the orange surface visible after the mcs tip cover accessory was installed.The mcs tip cover accessory was not installed beyond the orange surface.An installation tool was used.No electrolube or any other lubricant applied to the mcs instrument was used prior to the mcs tip cover accessory installation.No reducer was used and no difficulty in removing the instrument and mcs tip cover accessory.The instrument wrist did straighten upon removal.The surgical staff did not notice any damage on the mcs tip cover accessory, mcs instrument, or cannula after the event occurred.The procedure was completed laparoscopically.

Manufacturer Narrative

A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Isi has not received it for failure analysis investigations.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the tip cover accessory to perform failure analysis.The tip cover accessory was analyzed and found to have tearing at the mouth on the distal end.Tears are axially aligned with the tip cover and measure from 0.057¿ to 0.073¿ in length.There are no signs of thermal damage present at the end of any tears.Additionally, the tip cover was found to have gouged.The gouged tip was at the proximal end of the tip cover.The tip cover had hole or puncture near the distal end of the tip cover.The complaint was confirmed by failure analysis.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18667196
• MDR Text Key: 334847861
• Report Number: 2955842-2024-11134
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-08
• Device Catalogue Number: 400180
• Device Lot Number: L84230803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2024
• 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