MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; INSTRUMENT ARM DRAPE

Model Number	430013-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.However, failure analysis is not complete.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the instrument arm drape accessory white adapter part detached and became unusable during the arm replacement process.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did confirm and replicate the customer complaint "dislodged adapter".The accessory was found to have a dislodged adapter.Upon inspection, the instrument sterile adapter plate was found to be dislodged from the retainer.The instrument sterile adapter did not exhibit any obvious signs of physical damage.The sterile adapter plate was reseated back into the retainer, and the instrument arm drape was then placed on the in-house sp system for functional testing.All four magnets were attached to the system without any issues and all four sterile adapters successfully engaged on the arms.Initial fa was confirmed by the failure analysis engineer.The drape exhibits a dislodged sterile adapter plate on one of the four instrument sterile adapters.The root cause of the dislodged adapter plate is typically attributed to manufacturing.There were no additional findings with the drape when visually inspected.Probable root cause is attributed to manufacturing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: INSTRUMENT ARM DRAPE
• 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: 25021674
• Report Number: 2955842-2026-23107
• Device Sequence Number: 10332493
• Product Code: NAY
• UDI-Device Identifier: 00886874113486
• UDI-Public: (01)00886874113486(10)26ASA061
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 05/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430013-15
• Device Catalogue Number: 430013
• Device Lot Number: 26ASA061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2026
• 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.
• Patient Sex: Unknown