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

Model Number	480545-06
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform (sf) 45 curved tip stapler instrument to perform failure analysis (fa).Fa was not able to confirm nor reproduce the customer reported complaint.The instrument was tested on an in-house system.The instrument clamped, unclamped and fired successfully.The instrument fired successfully twice using green sf 45 reloads.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The instrument moved intuitively with full range of motion in all directions.Review of logs were unable to verify any failures.The instrument was fully functional.Further evaluation of the sf 45 curved tip stapler instrument found to have the snake wrist cover torn.The tears measured roughly 0.399".A visual inspection indicated that a fragment may have detached from the instrument; however, the size of the missing piece(s) could not be confirmed.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer closed the sureform 45 curved tip stapler instrument on tissue and when the surgeon went to fire the stapler, the stapler opened and then would not move again.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer stated the jaws opened when the surgeon activated the stapler which was the main malfunction.The jaws were not stuck on tissue.No adverse effects to tissue and no unexpected tissue removal.No bleeding when the issue occurred.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 CURVED-TIP
• 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: 25165191
• Report Number: 2955842-2026-24830
• Device Sequence Number: 16000217
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K11251127
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K11251127 0342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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