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	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 stapler instrument to perform failure analysis (fa).A visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument was placed on the in-house system and was found to be locked.The instrument generated an error message "instrument failure.Manual stapler release previously used on device.Do not reuse." the radio frequency identification (rfid) editor was used to unlock the instrument.The instrument was reinstalled on the in-house system and passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly on multiple attempts.Review of the logs was unable to verify any failures.The instrument was fully functional.There was no problem detected.The probable root cause cannot be determined based on the information provided and fa results.The reported event was not confirmed as fa found no functional issue.The instrument was visually inspected and evaluated for its mechanical and/or electrical characteristics.The fa investigations and in-house testing of the returned product revealed no issues related to the customer reported event.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer used the sureform 45 stapler instrument, and it would not open up.The sales representative was contacted, and the customer tried again.The instrument would not open up.A second stapler was used, and it would not work.The procedure was converted to laparoscopy with no reported injury.No known impact or patient consequence was reported.Intuitive followed up and obtained additional information.The customer informed both staplers were used on the same case/patient and were found out of the box failures.The instrument was inspected when it was taken right out of the box, and no damage was found on the box or instrument.The procedure was a robotic gastrojejunostomy.The customer was going to use the stapler on the stomach when the issue occurred.The customer was never able to get the instrument to work on the robot.The customer called the intuitive surgical, inc.(isi) sales representative for assistance over the phone, but it did not help.They opened a second stapler, and it still did not work.The jaws of the stapler never came in contract with the tissue or the patient.There was no bleeding.The procedure was converted to a traditional laparoscopic surgery.The patient tolerated the change; it just took longer.There was no injury to the patient as the procedure was completed, just not robotically.

• 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: 23513012
• Report Number: 2955842-2025-44323
• Device Sequence Number: 13230993
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)L17250612
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• 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): 11/10/2025

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: L17250612 0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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