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

Model Number	48230W-06
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a sureform 30 stapler instrument fired a white reload which did not fire as expected and resulted in staples missing from the staple line.A nurse who was present during this event reported that difficulties were experienced while loading the white reload into the stapler instrument and prior to being inserted into the patient.Although it was reported that staples were missing from the staple line, it was specified that there was no bleeding due to this event.The surgeon used a back-up instrument to continue the procedure.When asked if the surgeon continued the same staple line, stapled next to this white reload staple line, or took additional tissue, the nurse answered, "not applicable.".No images or videos were taken of this event.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The sureform 30 white reload was received for failure analysis investigations.The reported event with the accessory could not be replicated nor confirmed.Upon visual inspection, the reload appeared to be unused and unfired.No physical damage was observed.The reload was fired successfully with an in-house instrument when placed on an in-house system.All staples deployed from the reload.No product issue was identified.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.The sureform 30 stapler instrument used during this event was not received for investigations.

• 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: 25659796
• Report Number: 2955842-2026-29728
• Device Sequence Number: 10458736
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K11250717
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: K11250717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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