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

Model Number	430013-15
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the sp instrument arm drape was repeatedly inserted and the connection was successful, but an error message appeared.After replacing it with a new strap, normal operation resumed.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the accessory; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the instrument arm drape for failure analysis investigation.The accessory was analyzed and the findings did not replicate or confirm the customer reported event.For clarification, the entire drape was not returned and only one sterile adaptor was returned.The sterile adapter installed successful onto the in-house system multiple times without detachment issues or error messages.The sterile adapter passed recognition and engagement.A visual inspection was performed and there was no damage to the sterile adapter plate and input disks.The accessory was fully functional.
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: 24849078
• Report Number: 2955842-2026-21282
• Device Sequence Number: 15690016
• Product Code: NAY
• UDI-Device Identifier: 00886874113486
• UDI-Public: (01)00886874113486(10)1485LA0500
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430013-15
• Device Catalogue Number: 430013
• Device Lot Number: 1485LA0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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