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

Model Number	480445-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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.A review of the logs for the sureform stapler associated with this event has been performed by an isi failure analysis engineer.The following additional information was provided: the logs show pn 480445-06, ln l17250710-0210, was installed on the system 3x and fired 1 green reload.On the first install, the first clamp was successful, and the firing was completed with 1 pause for compression.On installs 2 and 3, the user manually selected the green reload on both installs.No clamping or firing was attempted on either install.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the msc logs.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the sureform 45 stapler instrument prompted a message to select the reload color.The customer questioned if the instrument was fully opened because there was an unusual movement and a suspected incomplete opening.The customer removed the instrument and visually inspected the instrument with no issues observed.The customer reused the instrument, but the surgeon was still suggesting that the instrument was not opening properly.The procedure was completed using a backup sureform stapler with no further issue reported.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up to obtain additional information.No jaws were stuck on tissue.There was no unexpected tissue removal.The jaws did not open as much as desired.There was no bleeding.Instrument is available for return.No patient information can be disclosed.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did confirm and replicate "during the procedure on the fourth case, after completing the first stapling, an unexpected message prompted the selection of the stapler reload color before proceeding with the second stapling".The instrument was removed from the patient to visually inspect the mechanism and verify any abnormality.No obvious issues were identified.Following this, the device was re-mounted (again requiring color selection) and attempted re-entry; however, the operator continued to express discomfort, suggesting the instrument was still not opening properly.Additional troubleshooting included adjusting the cannula depth to allow for smoother articulation and checking for any external obstructions, but these measures did not resolve the issue.As a result, a backup sureform instrument was used.With the backup device, the operator did not report any further concerns.The logs for the reported procedure confirms one engagement failure occurred on correlating installs of this instrument in the field.The parameters of the engagement failures indicate that the roll axis engagement failures is due to the corrosion observed on the roll bearings.The instrument inputs failed to engage with the in-house system's sterile adapter on quantity 3 of three (3) 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 engagement failures is due to the corrosion observed on the roll bearings.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45
• 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: 24283895
• Report Number: 2955842-2026-03369
• Device Sequence Number: 20912507
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(17)280731(10)L17250710
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: L17250710 0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/08/2026; 03/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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