MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK CADIERE FORCEPS

Model Number	476049-17
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the shaft of the dv5 force feedback cadiere forceps broke inside the patient and a fragment fell inside the surgical field.The fragment was retrieved.The procedure was completed.
Additional Manufacturer Narrative
Additional information obtained it was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the force feedback cadiere forceps broke inside the patient.The customer stated they were retrieving the pieces that broke.The procedure was completed robotically.The patient was hospitalized approximately one week later due to an infection.The patient required a subsequent procedure where additional pieces of the cardiere forceps instrument were retrieved.The patient is reported to be recovering well.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK 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: 23300950
• Report Number: 2955842-2025-40800
• Device Sequence Number: 20049649
• Product Code: NAY
• UDI-Device Identifier: 00886874125564
• UDI-Public: (01)00886874125564(10)U11250520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 476049-17
• Device Catalogue Number: 476049
• Device Lot Number: U11250520 0134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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 Sex: Unknown