MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; CANNULA, STANDARD, REUSABLE

Model Number	470002-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tip was bent, and a piece of the black part fell inside the patient, but the doctor retrieved it.The procedure was completed.
Additional Manufacturer Narrative
The cannula seal has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cannula/seal were returned still attached to a fenestrated bipolar forceps instrument.They were analyzed, and the complaint was not confirmed by failure analysis.An investigation was completed.No damage was found.Additional information was obtained from the customer regarding the complaint: a fenestrated bipolar arm was in use during a robotic assisted laparoscopic myomectomy case.The arm stopped moving and the first assist saw that the tip of the arm would not straighten out.An emergency instrument release device was retrieved and used in an attempt to take the arm out through the trocar but it was unsuccessful.Due to the fact that the arm could not straighten out completely, the only way to take it out was to take the entire trocar out along with the arm.Upon exit, a piece of the wire that had snapped, broke off and went into the interior of the abdominal wall.It was spotted and retrieved easily leaving no damage.A new arm was placed with a new trocar, and the procedure was completed successfully.An abdominal x-ray was taken out of an abundance of caution to give another diagnostic tool to confirm that there was not any other metal in the abdomen.The surgical task being performed during the device breakage was lifting the uterus.The surgeon did not notice any issues with the functionality of the instrument.The accessory did not collide with any other instruments or other hard material during the surgical procedure.The fragment fell inside the patient due to an instrument tip / accessory collision.The accessory was not removed during the procedure, prior to the breakage.The surgical staff felt resistance upon removal of the instrument; it remained bent and unable to straighten.There was no damage noted to the cannula after the accessory was removed.The fragment was retrieved, and it was confirmed through examination and looking around the belly.No additional surgical procedure was required to remove the fragment.The procedure was completed robotically.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The accessory is available for return; however, a fragment was thrown away.There were no photographic images of the devices or video recording of the procedure available for isi review.No further information was available.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI
• Common Device Name: CANNULA, STANDARD, REUSABLE
• 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: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 22469190
• Report Number: 2955842-2025-29306
• Device Sequence Number: 4234991
• Product Code: NAY
• UDI-Device Identifier: 00886874112137
• UDI-Public: (01)00886874112137(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470002-07
• Device Catalogue Number: 470002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 80 KG