MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number	48345T-03
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc (isi) did not receive a da vinci product to perform failure analysis.Sureform 45 stapler instrument logs show that the instrument (part number 480445-06, lot number k10260128-0387) was used first and was installed on the system 8 times and fired 8 reloads (1 white, followed by 7 black).On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used in the procedure again.The second sureform 45 stapler instrument (part number 480445-06, lot number k12251121-0336) was installed on the system 3 times and fired 3 black reloads.On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted transthoracic esophagectomy procedure, the sureform 45 black reload produced a tissue pushout event twice on stomach tissue.The first tissue pushout event occurred with the first sureform 45 stapler instrument, which had multiple prior successful reload firings.While attempting to fire a black reload on stomach tissue, the tissue was pushed out along with the staples out of the jaws of the reload.A new sureform 45 stapler was then opened along with a new sureform 45 black reload from the same lot as the prior fire.The same issue occurred again.A new black reload was then used a different lot with the second sureform 45 stapler, and the issue was resolved.The procedure was completed robotically with no further complications.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: 25411232
• Report Number: 2955842-2026-27556
• Device Sequence Number: 9465362
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)K11250918
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 48345T-03
• Device Catalogue Number: 48345T
• Device Lot Number: K11250918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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: 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