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

Model Number	48360B-10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.Stapler logs showed sureform 60 (lot number: k10251112-0112) was used first and installed on the system intermittently.It was installed on the system 2 times and fired 2 blue reloads.On each install, all clamp attempts were successful, and the firings were each completed with no pauses for compression.Next, sureform 60 (lot number: k11251115-0362) was installed on the system intermittently.It was installed on the system 10 times and fired 10 reloads (9 blue and 1 white).On installs 1-6, all clamp attempts were successful, and the firings were each completed with no pauses for compression.On installs 7 and 8, the system failed to detect the reload color.On install 7, the first clamp was successful, and the firing was completed with 2-3 pauses for compression.On installs 8 and 9, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 10, the first clamp was successful, and the firing was completed with 1-2 pauses for compression.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted transthoracic esophagectomy chest anastomosis surgical procedure, a sureform 60 stapler with a blue reload misfired and had a misaligned staple line.No fragment fell into the patient.It is unknown if any intervention was required to address the misaligned staple line.The procedure was completed with a delay of less than 15 minutes.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 25330707
• Report Number: 2955842-2026-26780
• Device Sequence Number: 13242524
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K14251030
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: K14251030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2025
• 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: Other
• Patient Sex: Unknown