MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD WHITE

Model Number	48360W-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 60 stapler instrument read the wrong color.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 60 stapler instrument and multiple white reload accessories to perform failure analysis.The instrument was analyzed and was found to have a lodged staple in the i-beam assembly.As a result, the bevel spur gear was binding , and i-beam had stalled in the lockout area, which cause the instrument to fail reload recognition.A review of logs further confirmed that instrument had multiple reload recognition failures.The white reload accessories that were an associated products returned with the stapler instrument were analyzed by failure analysis team.The accessory (48360w-08) was returned fully fired.Visual inspection showed that reload had a lodged staple that was wedged behind the exposed knife at the blade stopping point.Further inspections showed that reload had a cartridge damage.A piece of the cartridge was found to be wedged in between the reload at the front end of the exposed knife, causing it to jam.The piece was removed and the shuttle was found to be fully deployed.The reload cover was removed, the shuttle was pulled forward to allow access to the knife.The blade was found to be damaged and had mechanical indentations on it.The probable root cause of lodged staple is attributed partially or wholly to the misuse/mishandling of the device including sample handling.
Additional Manufacturer Narrative
The sureform 60 stapler instrument and multiple white reload accessories were re-evaluated by the intuitive surgical inc., (isi) quality engineering (qe) team.Following information was obtained : the probable root cause of the reported complaint is attributed to loose staples from firing across staple lines or not having a full bundle of tissue between the jaws during use.Loose staples that do not go into tissue can be dragged into the i-beam slot as the i-beam retracts during unclamping.Increased drive train friction during calibration due to a staple lodged in the path of the i-beam can prevent the instrument from registering the reload color, which then results in an initialization failure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD WHITE
• 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: 23041966
• Report Number: 2955842-2025-37662
• Device Sequence Number: 9832897
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• 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,Followup
• Report Date (Section B): 08/19/2025

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: 48360W-08
• Device Catalogue Number: 48360W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White