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	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, user informed the technical support engineer (tse) that the fenestrated bipolar forceps (fbf) instrument on arm 1 could not be detached, and both the instrument removal and instrument release buttons were unresponsive.The tse was informed that the instrument was ultimately removed by holding down the instrument removal button while pulling on the instrument.The tse suspected poor contact at the drape sterile adapter and requested that it be reconnected, after which arm 1 recognized the instrument normally.Subsequently, arm 3 failed to recognize an instrument even after it was replaced, and tse suspected a faulty drape and advised drape replacement.The user continued with the procedure using the same system configuration without further issues.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp instrument arm drape for failure analysis investigation.The accessory was analyzed and the reported event could not be replicated.The instrument arm drape was placed on the in-house sp system for testing.All four magnets were attached to the system without any issues and all four sterile adapters successfully engaged on the arms.An in-house sp instrument was then placed on the in-house system.The instrument passed the recognition and engagement tests, indicating a fully functional drape.Upon visual inspection, there was no signs of physical damage and no missing or dislodged components.No product issue was identified.

• 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: 25046899
• Report Number: 2955842-2026-23044
• Device Sequence Number: 16066628
• Product Code: NAY
• UDI-Device Identifier: 00886874113486
• UDI-Public: (01)00886874113486(10)3465LA0400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/30/2026

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: 3465LA0400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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