MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number	48630G-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 30 green reload was analyzed and found to have the knife exposed within the knife track.The knife was exposed towards the proximal end of the returned reload.The reload was found to have cartridge damage.The reload cartridge had mechanical indentations from exposed component.There was no material missing as a result.The complaint was confirmed by failure analysis.A blade exposed icon and message will appear if the firing sequence is interrupted.The probable root cause of the exposed component can be attributed to various factors.These factors may include instrument damage, particularly in the wrist area, tissue condition (e.G., disease state and density), and foreign objects (e.G., metal clips) that can cause stapler firing forces to exceed the prescribed limit and subsequently result in a partial fire.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer was attempting to stapler the bronchus using the stapler 30 instrument and green reload.During firing, the instrument stopped with a message ¿remove stapler warning blade may be exposed." subsequently, a message appeared ¿unable to complete fire.Tap blue pedal to unclamp then remove stapler.Warning blade may be exposed." therefore, the customer removed the stapler and replaced it with a sureform 60 green reload and started stapling.It was observed that some of the titanium staples were stuck in the stapler/reload without being engaged.No fragment fell into the patient.The customer completed the procedure, and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred on the first stapler fire.Bronchus stapling was being performed at the time of the event.The bronchus was the target tissue.The tissue was not calcified.The tissue was not exposed to any radiation or chemotherapy prior to the procedure.There was not any tissue tension.There was not any tissue bunching.The issue involved a partial fire.The issue resulted in unformed staples that were in the ¿u¿ shape/form.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The surgeon did not fire over an existing staple line.The buttress material was not used.The surgeon did not experience any clamping issues prior to firing the stapler reload.There was not any bleeding observed on the staple line due to the stapler issue.There was no unplanned tissue removal due to the stapler firing failure.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 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: 21254018
• Report Number: 2955842-2025-00599
• Device Sequence Number: 9060018
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(17)250930(10)K10230928
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2025

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: K10230928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: 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