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

Model Number	48360B-08
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of the date of this report, the sureform 60 blue reload has not yet been received by intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.The sureform 60 stapler involved with this event has been received, but the failure analysis testing has not yet been completed as of the date of this report.
Event or Problem Description
It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the sureform 60 stapler could not be used even after trying 2 reloads.A third reload was used and a blade fell out.The user was completing the procedure as planned with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no damage to the other two reloads.There was no instrument collision during the procedure.There was no fragment fall into the patient and no injury to the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform (sf) 60 stapler to perform failure analysis (fa).Fa was not able to confirm nor reproduce the customer reported complaint.The instrument was placed and driven on the in-house system and the instrument passed initialization.The instrument passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions and the jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was successfully fired with a sf 60 black reload.Visual inspection was performed and no damage was observed.The instrument was fully functional.No product issue was found.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24374310
• Report Number: 2955842-2026-04751
• Device Sequence Number: 4875410
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)L90210831
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360B-08
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• 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: Unknown