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

Model Number	48360W-08
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, the sureform 60 stapler instrument started to fire, but the tissue was too thick.The surgeon tried to retract the blade, and it locked up.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 60 white reload to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The reload was found to have lodged staples wedged in the knife track.The staples were removed and there were 3 staples confirmed.There was also cartridge damage, and the blade appears to be exposed.Additional observations related to the customer reported complaint: the reload was found to have the knife exposed within the knife track.A log review confirms the reload was not involved in a firing failure.The knife was exposed towards the middle of the returned reload, which does not align with the firing completion percentage displayed in the procedure logs.Visual inspection confirms there are 3 lodged staples ahead of the blade stopping point, which can prevent the blade from progressing through the full firing trajectory.The exposed blade was likely caused by the lodged staples.The instrument was found to have blade damage.The blade edge was indented, which prevents the blades from cutting properly.The reload cartridge had mechanical indentations resulting from the exposed blade.There was no material missing as a result.Isi also received the sureform 60 stapler instrument to perform fa.Fa was not able to confirm and reproduce the customer reported complaint.The instrument passed the recognition and engagement tests on all attempts.The instrument moved intuitively with full range of motion in all directions.The instrument clamped, fired and unclamped as expected during testing.The grips opened and closed properly.There were no failures reported in the logs.No physical damage was observed.The instrument was fully functional.

• 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: 20434677
• Report Number: 2955842-2024-20412
• Device Sequence Number: 8488228
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 05/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/11/2024
• 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 Sex: Prefer Not To Disclose