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

Model Number	48360B-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted right hemicolectomy surgical procedure, an incomplete staple line was identified after a blue sureform 60 reload was fired with a sureform 60 stapler instrument.The initial reporter claimed that half of the stapler fired and the other half was wide open.The stapler instrument reportedly did not fire, but it cut.No bleeding was reported.The surgeon then chose to convert the case to open surgery due to the issue.The system did not display any errors.This event resulted in a less than 15 minute surgical delay.
Additional Manufacturer Narrative
A review of the stapler logs associated with the event revealed the following: the logs show a sureform 60 stapler instrument (part #480460-12, lot #t10240529-0306) was installed on the system 1 time and fired 1 blue sureform 60 reload.On the only install, the first clamp was successful, and the firing was completed with no pauses for compression.The instrument was then removed and not used again in the procedure.There were no stapler related errors in the logs.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The sureform 60 stapler and sureform 60 blue reload associated with this complaint were analyzed by the failure analysis team and the findings did not replicate or confirm the customer reported event.The instrument and reload were fully functional.No product issues were identified.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLUE
• 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: 21658359
• Report Number: 2955842-2025-08649
• Device Sequence Number: 18250565
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(17)270930(10)K14240913
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360B-10
• Device Catalogue Number: 48360B
• Device Lot Number: K14240913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown