MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230W-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis replicated and confirmed the customer reported complaint ¿when the customer removed the stapler 30 white reload, the part was broke".The instrument was found to have the switch dislodged from the tail.The reload was returned in an open original package with the installation and removal tool.The dislodged switch was dislodged from its location and had an indentation on one of the edges of the switch.Visual inspection showed all staples and pushers were intact.No missing material was observed.The cartridge passed visual inspection.The probable root cause of reload damage is attributed to high firing torques, which can result from firing on challenging tissue (e.G., tissue condition) or hard objects (e.G., staples).This issue can be resolved by using an alternate accessory to complete the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer was unable to install the stapler 30 white reload.When the customer removed the stapler 30 white reload, the part was broken.The user completed the procedure and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive followed up and obtained additional information.A fragment didn¿t fall inside of the patient¿s anatomy because this event occurred before insertion of the instrument into the patient's body.Reload is available for return.No other information is available.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24285514
• Report Number: 2955842-2026-03676
• Device Sequence Number: 21282790
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K12250522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• 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,Followup
• Report Date (Section B): 02/13/2026

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: 48230W-06
• Device Catalogue Number: 48230W
• Device Lot Number: K12250522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/07/2026
• Supplement Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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