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

Model Number	48360G-08
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the surefrom 60 stapler instrument jaws did not open well.The instrument jaws were stiff when operating from the surgeon side console (ssc).When the customer used the green reload to staple the patient¿s tissue, a message ¿tissue too thick¿ appeared.The customer replaced the green reload with the black reload, but the same message was generated.The customer replaced with a new stapler instrument, but the issue persisted.After this, the customer clamped half of the tissue and attempted to fire; however, a message ¿tissue too thick¿ reappeared after a partial fire.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the stapler instruments and reloads were inspected prior to use with no issue.The reported event was involved during the first fire of the second stapler instrument.Partial fire issue occurred when the customer was stapling the stomach tissue.The stapling issue did not result any of the followings: malformed/unformed staples, exposed blade, missing staple line, holes/gaps within the staple line, reload being stuck to tissue.The message was generated when the stapling issue occurred was ¿tissue too thick¿.The surgeon did not encounter any obstructions and did not fire over an existing staple line.There was no unexpected bleeding or unplanned tissue removal.The customer used a third-party stapler to continue with the procedure.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product to perform failure analysis.The sureform reload was analyzed and found to have the knife exposed within the knife track.The reload was not returned with an instrument so the procedure logs were unable to be retrieved.The exposed blade confirms a firing failure.The knife was exposed towards the proximal end of the returned reload.Visual inspection confirms there is 1 lodged staple.The staple was lodged inside of one of the pushers, and not in the knife track.There was no cartridge damage or blade damage to the knife observed.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• 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: 20196571
• Report Number: 2955842-2024-19239
• Device Sequence Number: 7584025
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)K10230504
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: Other
• Device Model Number: 48360G-08
• Device Catalogue Number: 48360G
• Device Lot Number: K10230504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: Reuse
• 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