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	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci assisted roux-en-y procedure, a sureform 60 stapler instrument fired a sureform 60 blue reload on the stomach, but did not apply staples and the stomach tissue was cut open.It was reported that the stapler worked before and after this event without issues.The indication for the procedure was weight regain in morbid obesity (obesity grade iii).The complication occurred during resizing of the gastric pouch, while firing the fourth stapler reload of the procedure.The affected staple line resulted in about 200ml of blood loss.The surgeon sutured the staple line with stratafix to resolve the complication and continue the procedure.No additional tissue was taken due to this event.This event resulted in a delay, instar-operative gastroscopy, and extended inpatient monitoring.The patient did not experience any post-operative complications and their treatment plan was not changed due to this event.The patient was reported to be doing well.The surgeon was not able to state what caused this event, it was added that there was no error message or notification from the da vinci system when this event occurred.
Additional Manufacturer Narrative
The sureform 60 blue reload accessory used during this event has not been received for failure analysis investigation.The stapler logs for this procedure were reviewed.The logs show the surefom 60 stapler instrument used during this procedure was installed on the system 10 times and fired 10 surefom 60 reloads (9 blue, followed by 1 white).On install 7, the first clamp was successful, but was followed by a firing failure.

• 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: 24546544
• Report Number: 2955842-2026-15425
• Device Sequence Number: 21203563
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K12250821
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: K12250821 2460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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