MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CADIERE FORCEPS

Model Number	478055-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a broken grip at the grip base.A piece approximately 0.200 in x 0.951 in was found to be broken off.The broken piece was returned with the instrument.Further inspection found a broken distal clevis.Two pieces approximately 0.216 in x 0.313 in were found to be broken off.The broken pieces were not returned.The fragments originated from the broken blade.
Event or Problem Description
It was reported that during a da vinci-assisted sacrocolpopexy with hysterectomy surgical procedure, the tip of the cadiere forceps broke and fell inside of the patient.The fragments were retrieved during the same procedure.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use.It is unknown what task was being performed at the time of the device fragment falling into the patient.It is unknown what the surgeon believed was the cause of the instrument break.The customer was not sure if the surgeon noticed any issues with the functionality of the instrument during the procedure.It was not reported that the instrument collided with any other instrument or other hard material during the surgical procedure.It was not reported if the surgical staff felt any resistance upon removal of the instrument through the cannula.The customer was not able to answer if fragments that fell inside of the patient were retrieved.The customer performed a visual inspection of irrigation in intrabdominal cavity.No additional surgical procedure was required to remove the fragment.No post-operative tests, such as an x-ray or ultrasound, were performed to check for remaining fragments.The procedure was completed robotically.The patient has not returned to the hospital due to experiencing any post-surgical complications related to foreign after.The instrument and the fragment have been returned.No past medical or surgical history per medical record.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE FORCEPS
• 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: 21902039
• Report Number: 2955842-2025-16746
• Device Sequence Number: 12939905
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(11)240620(10)K10240620
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 478055-04
• Device Catalogue Number: 478055
• Device Lot Number: K10240620 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: Reuse
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White