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	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 30 curved tip stapler instrument and white reload accessory to perform failure analysis.The accessory was analyzed and it was found to have a broken cartridge tail.The tail exhibited a fracture point, but no missing material was observed.The material was not fully detached.Visual inspection was performed and the reload was found to have a dislodged switch.The reload was returned unused and unfired.The accessory was re-evaluated by engineering team and initial findings were confirmed.The switch was not returned with the reload.The most probable root cause of the broken tail and dislodged switch are attributed to the user mishandling.Tail breakage, along with switch dislodgement, suggested a potential sharp angle of insertion of the reload into the instrument channel.It was likely that the sharp angle of insertion allowed the tail portion of the reload to interact with components at the back of the channel, such as the lockout mechanism or lockout cover.The switch was likely bent and pulled from the tail during attempts to seat the reload while it was misaligned within the channel.Proper use of the installation tool will ensure the reload tail and switch are aligned within the channel during seating and can prevent damage to the reload.The sureform stapler instrument was analyzed and it was found to have 12 lives remaining.Visual inspection was performed and no damage was observed.The instrument was tested on an in-house system where it passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument initialized, clamped, fired, and unclamped without any issues twice.The instrument was fired with sf gray and blue 30 reloads.The instrument was fully functional.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 30 curved tip stapler did not fire.The user completed the procedure with no further issue reported.The instrument was not used on the patient.

• 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: 22681800
• Report Number: 2955842-2025-32335
• Device Sequence Number: 8892226
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 48230W-06
• Device Catalogue Number: 48230W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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