MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45

Model Number	480445-06
Medical Device Problem Code	Difficult to Open or Close (2921)
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, the jaws would not unclamp on the sureform 45 stapler.The procedure was completed with no reported injury.Intuitive followed up with the initial reporter to obtain additional information, however, no further details are available regarding the reported event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary failure of lodged component to be related to the customer reported complaint.The instrument was found to have a lodged staple in the i-beam assembly.Logs show a failure in initialization.The instrument was placed on a in house system and passed initialization.The i-beam assembly was extended, and a staple was found to be lodged inside.The instrument was found to have repeated clamping failures within a single install based on log review.The instrument was functionally tested on an in-house system and achieved adequate compression on a test foam with a color reload installed.The instrument was found to fail during initialization based on log review.The staples were removed, and the instrument was reinstalled on the in-house system.It passed the initialization, recognition and engagement tests on 3 of 3 attempts.Root cause is attributed to component susceptibility to damage.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45
• 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: 25084565
• Report Number: 2955842-2026-23692
• Device Sequence Number: 10433488
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K11251105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• 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
• Report Date (Section B): 05/05/2026

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: K11251105 0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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