MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	488530-13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The reported event with the instrument could not be replicated nor confirmed.Review of the logs found no errors related to the instrument.Engagement logs show 2 successful engagement attempts, however there is no clamp, unclamp or fire sequence in the logs.The instrument was returned with 12 / 12 uses remaining.The instrument could not be tested for clamp, unclamp and fire in-house due to the fact that the instrument failed the engagement test on multiple attempts when installed on the system.The stapler instrument was found to have failed mechanical engagement during in-house testing.The instrument inputs failed to engage with the in-house system's sterile adapter on three of three attempts, preventing the instrument from entering into following.The error logs for the system installs display error code 22020, with parameters indicating that the roll axis failure.High friction was observed when rotating the instruments main tube manually.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer reported the stapler would not open during case, would not fire.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the jaws were not stuck on tissue when the issue occurred.No unexpected tissue removal.No bleeding observed.The instrument was sent in for analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Initial findings were confirmed by advanced failure analysis.The procedure logs were reviewed and confirmed the instrument was installed without issue two times during the procedure.No clamping or firing was attempted, per the logs.The instrument was re-installed on an in-house system and failed to engage on each attempt.Error code 22020 was shown in the system logs, with parameters indicating that the roll axis failed to engage.Roll axis failure is related to increased friction along the main tube, caused by the corrosion along the roll bearing.Corrosion develops after a procedure, and during transit and/or storage, and would not be related to the reported jaw issues.Visual inspection did not find any damage.The instrument driver was extended and retracted without issue.The jaws opened and closed manually without issue.The reported complaint could not be confirmed, nor replicated.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 22312916
• Report Number: 2955842-2025-26585
• Device Sequence Number: 8857856
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)U10250416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 488530-13
• Device Catalogue Number: 488530
• Device Lot Number: 0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: Reuse
• 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