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

Model Number	48360T-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted liver resection surgical procedure, sureform 60 stapler only fired 9 times out of it's intended 12.Upon loading it after the 9th fire the sureform would not fire.The customer removed the stapler and continued with another of the same.The procedure was completed with no reported injury or delay.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis (fa).The sure form stapler 60 black reload was analyzed and found to be returned already fired.All pushers deployed and no unformed staples found.The blade was at the distal end and not exposed.No blade or cartridge damage was found.However, the reload was found to have a lodged staple in the knife track and was found to have cartridge damage.The damage was located along the knife track.Isi did receive the sure form stapler 60 to perform fa.Review of logs showed 3 installation attempts with the stapler but a ¿lockout error was recorded after the 9th fire.This error is expected condition when a used reload or no reload is going through the initialization process.¿missing or used reload¿ error message would be displayed on the monitor screen.During the initialization process, the i-beam touches off of the shuttle to determine reload position and color.Because of this principle, the reload was either used or no reload was installed when the stapler 60 was installed.No i-beam damage was observed.No loose or lodged staple was observed in the i-beam window.The instrument was placed on the system with a new reload.No initialization failures or errors/faults occurred during in-house testing.The instrument moved intuitively with full range of motion in all fire directions.Clamp and fire test passed on test sheet.Additional information: logs showed 1 firing failure due to high torque.Instrument was able to pass initialization during failure analysis.Clamp and fire function passed with no issue on test sheet.Staple formation was proper.No i-beam damage was observed.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLACK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18460838
• Report Number: 2955842-2024-10065
• Device Sequence Number: 16916085
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)T90211108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: 48360T-08
• Device Catalogue Number: 48360T
• Device Lot Number: T90211108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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