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	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the sureform stapler and reload instrument associated with this complaint and completed investigations.The reported event with the instrument could not be replicated nor confirmed.Failure analysis could not verify the customer reported event.The instrument was installed on an in-house system and passed the initialization test.The instrument jaws were opened using the system.The instrument was then removed from the system to remove the returned reload.An in-house reload was then installed on the instrument.The instrument was placed on the in-house system and again passed initialization.The instrument moved intuitively with full range of motion.The instrument was then tested for fire and fired a gray and white reload successfully with no issues.Review of the logs found no errors related to the instrument.The instrument was returned with 12/12 uses remaining.The reload was removed from the instrument for inspection.The reload was returned unfired.The reload was inspected and found to have no physical damage.All the staples remained in the reload pockets as expected.No reload damage was observed.The reload was re-installed onto an instrument and the instrument passed the initialization test.The reload was then fired successfully with no issues.The probable root cause cannot be determined based on the information provided and failure analysis results.No product issue was identified during in-house testing.Blank mdr fields: the missing patient information in section b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the sureform stapler jaws were slow to open, needed to be forced open, surgeon stated that it felt like the power was not on.The procedure was completed with no reported injury.

• 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: 22922691
• Report Number: 2955842-2025-34867
• Device Sequence Number: 9162046
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)K10250205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 925 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White