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

Model Number	480545-06
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical inc., (isi) field service engineer (fse) was dispatched to the site to further investigate the reported event.Fse inspected the system but was unable to replicate the reported event on the universal surgical manipulator (usm1) of patient side cart (psc).The system was tested and verified as ready for use.The stapler instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the wrist of stapler instrument moved by itself when installed onto the universal surgical manipulator (usm1) of patient side cart (psc).The issue happened when customer was trying to remove the instrument from the usm and the customer had to remove the instrument and the trocar together.The customer replaced the stapler instrument with a backup and the procedure was completed as planned.An intuitive surgical inc., (isi) technical support engineer (tse) recommended returning the stapler instrument for failure analysis.Customer requested the usm1 to be checked.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical inc., (isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon's head was inside the surgeon console's high resolution stereo viewer (hrsv).The issue occurred while the surgeon was attempting to manipulate the instruments from the ssc.The issue was related to instrument remaining static.The stapler locked into the place and had to be removed together with the trocar.The instrument moved unintentionally.The timing of instrument movement was not appropriate.There was no shakiness and/or friction to be observed.There were no instrument-to-instrument or system arm-to-arm interferences.There were external collisions.The customer was unsure if the instrument was returned or disposed.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23720811
• Report Number: 2955842-2025-46563
• Device Sequence Number: 18247944
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(17)280531(10)K18250515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K18250515 0318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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