MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number	480460-12
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the instrument for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) surgical procedure, the sureform 60 instrument stopped functioning after the installation of a fourth sureform 60 stapler reload.Position in reverse in the abdomen.The sureform 60 instrument was removed, then the universal surgical manipulator (usm) was reset via the trocar button.The sureform 60 instrument was longer recognized.A message was displayed not engaged, while the other staplers functioned correctly and were recognized.The customer completed the procedure and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the instrument was moving in an undesired direction.The desired direction was right, but it was moving to the left.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 60 stapler instrument to perform failure analysis.The sureform 60 stapler instrument was found to have a misaligned roll gear, with the roll gear tooth out of alignment with the idler gear.As a result, the main tube could be rotated past its hard stop, likely leading to the engagement failures observed.Additionally, mechanical engagement failures were identified during both log review and in-house testing.Logs from the reported procedure confirmed six engagement failures corresponding with this instrument¿s field installs.During in-house testing, instrument inputs failed to engage with the sterile adapter on all three attempts, preventing the instrument from proceeding further.The complaint was confirmed by failure analysis.The probable root cause is attributed to increased friction along the roll axis.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60
• 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: 24815721
• Report Number: 2955842-2026-20734
• Device Sequence Number: 6011705
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K12251003
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K12251003 0362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG