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

Model Number	480545-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.Review of the provided video was performed by an intuitive surgical, inc.Failure analysis engineer.The following additional information was provided: in the video, the surgeon was using a sureform 45 instrument on lung tissue.During the fire, the instrument partial fires, which is expected instrument behavior when encountering high firing forces.Staples were deployed into tissue past the distal end of the cut line, as intended.There were no observable injuries in the video.The missing patient information in sections a and 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.Information for the blank fields in section e1 is not available.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 surgical procedure, the sureform 45 stapler instrument could not be triggered.The procedure was completed with no patient harm, adverse outcome or injury.The issue caused a delay of less than 15 minutes.No known impact or patient consequence was reported.Intuitive followed up and obtained additional information.It was a partial triggering of the stapler.After initially closing without any warnings, the stapler suddenly got "stuck" about halfway through and continued to compress for a very long time, even though the parenchyma was obviously not particularly thick.A message then appeared stating that the tissue was too thick, and after confirmation, the stapler retracted and opened.It was not possible to remove the magazine from the stapler.A new stapler continued to staple the parenchyma in the same place without any problems.The incident was recorded on video and can be viewed if necessary.Intuitive followed up and obtained additional information.After the stapler was opened, there were still staples in the magazine.Some staples in the stapler seam were also not stapled, but still 'open'.

• 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: 24250816
• Report Number: 2955842-2026-03030
• Device Sequence Number: 18201201
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K10250530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190999
• 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): 02/03/2026

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: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K10250530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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