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	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 30 curved tip stapler instrument to perform failure analysis, and the complaint was confirmed.The sureform 30 curved tip stapler instrument was found to have one unclamping failure based on log review.The instrument was installed on an in-house system and found to have been forced locked.It was noted the sureform 30 curved tip stapler instrument had generated an "instrument failure.Do not reuse." error message.An engineering software confirmed the sureform 30 curved tip stapler instrument had been forced locked and the same software was used to unlock.An in-house reload was installed onto the jaws of the instrument and re-installed onto the in-house system and passed the initialization test.The reload was fired successfully onto a test sheet.The probable root cause of the sureform stapler instrument experiencing unclamping issues is attributed to obstructions in the path of the i-beam.In the event that the da vinci system is unable to unclamp the sureform stapler instrument normally, the user will be presented the option to force unclamp on the surgeon console touch pad.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the firing went well with sureform 30 curved tip stapler instrument until the clamping action had to be released.Then a message appeared and the stapler became difficult.After releasing the clamping action, the stapler indicated it could no longer be used.The procedure was completed with no patient harm.Intuitive surgical (is) obtained the following additional information regarding this event: the stapler made an announcement that it could no longer be used.The customer used more than one back up instrument to complete the procedure.The first back-up stapler gave the same error/massage.The procedure was completed robotically.

• 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: 25381016
• Report Number: 2955842-2026-27022
• Device Sequence Number: 9279586
• Product Code: GDW
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)K10250529
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K211997
• 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): 06/03/2026

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: 488530-13
• Device Catalogue Number: 488530
• Device Lot Number: K10250529 0191
• 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: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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