MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; SEAL

Model Number	470500-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The universal seal has not been received for failure analysis evaluation.A review of an image provided by the customer was performed.The image appears to show a universal seal with a torn duckbill component.
Event or Problem Description
It was reported that during a da vinci-assisted abdominoperineal resection procedure, a small black piece from the universal seal was identified in the patient's pelvis.The fragment had reportedly fallen inside the patient and was retrieved during the same procedure.The customer stated that no damage to the universal seal was identified prior to use.Towards the end of the procedure, a piece of plastic was observed in the patient's pelvis.A laparoscopic grasper was already inserted through one of the ports at the time.The surgeon suspects the fragment might have broken off during insertion or withdrawal of either a robotic instrument from port #3 or #4 or a laparoscopic grasper instrument.The fragments were removed using a laparoscopic grasper.An inspection of the universal seal confirmed that only a single piece had broken off.No postoperative imaging, such as x-ray or ultrasound, was performed to check for retained fragments.The patient has not returned with any postoperative complications.

• Brand Name: DA VINCI
• Common Device Name: SEAL
• 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: 25477587
• Report Number: 2955842-2026-28122
• Device Sequence Number: 18432963
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)K11260205
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 470500-14
• Device Catalogue Number: 470500
• Device Lot Number: K11260205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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