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	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one needle had come off the stapler 30 white reload before it was installed in the sureform stapler instrument.Furthermore, several needles fell off when installing the other stapler 30 white reload.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the event occurred when unpacked before placing the reload into the jaw.Patient was not involved in this event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The reload stapler 30 accessory was analyzed and the reload was found to have a broken tail with no material missing as a result of the break.Additionally, three staples were found to be missing from the proximal end pockets of the unfired reload.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of the broken tail and missing staples is attributed to damage during use.

• 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: 24571898
• Report Number: 2955842-2026-15782
• Device Sequence Number: 20921557
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K11240717
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: K11240717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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