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	Insufficient Information (4580)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, fabric was pushed when a blue sureform 60 reload was fired with a sureform 60 stapler instrument.As a result, a partial staple fire occurred.This issue occurred with two blue sureform 60 reloads from the same batch.No fragments fell inside the patient.The issue caused a delay of less than 15 minutes.It is unclear if any tissue was damaged due to the customer reported issue and if any medical/surgical intervention was rendered.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the blue sureform 60 reload to perform failure analysis; results are pending investigation.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated fields: h2, h3, h6, and h11.Device evaluation: the blue sureform 60 reload was returned to intuitive surgical, inc.(isi) for evaluation.The blue sureform 60 reload was analyzed and found to have loose staples stuck in front of the knife.Additional information: a review of the stapler logs was performed for this procedure.The log review shows that all 15 of 15 attempted fires across the three sureform 60 stapler instruments used were successful.There were no incomplete clamps, partial fires, engagement failures or unclamp failures.All firings were completed with no pauses for compression.The sureform 60 stapler instrument failed to initialize on the last four installs of its use, after six successful fires, and was not used again.There were no stapler related errors in the logs.

• 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: 22900652
• Report Number: 2955842-2025-35542
• Device Sequence Number: 5828799
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K13241107
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48360B-10
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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: ISIFA2022-02-C
• 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