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

Model Number	48360G-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Biliary Leak (4820)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted transthoracic esophagectomy with chest anastomosis procedure, the patient experienced a staple line leak less than 24 hours postoperatively.The leak originated from the midsection of the linear staple line on the gastric tube, where a green sureform 60 reload had been utilized.While the proximal and distal ends of the staple line displayed appropriate b-shaped staple formation, the central segment exhibited inadequate staple formation.This defect resulted in leakage of bile and gastric secretions into the right thoracic cavity.Initial revision was attempted via thoracoscopy but had to be converted to open thoracotomy due to poor cardiopulmonary status.The leak was repaired using suture, and a lavage of the thoracic cavity was performed.The procedure was completed, and the patient was subsequently transferred to the intensive care unit (icu).The patient did not experience any post-operative complications.Endoscopic images were reviewed, and documented the staple line insufficiency, showing bile surrounding the wound (not necrosis).Intraoperatively, the surgeon observed no technical issues; the staple line appeared intact, and standard stapling procedures were followed.Organ perfusion appeared excellent, as reflected in the uncomplicated healing of the higher esophagogastric anastomosis.Following these events, the surgeon switched to using only blue sureform 60 reloads for the gastric tube formation and began oversewing the first staple line; despite noting this had not previously been necessary and introduces potential risks.Based on other cases, this early leak was unusual.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.A review of the stapler log shows that the sureform 60 stapler instrument (lot number: k14250215-0437) was installed 7 times and fired 6 stapler reloads (1 green followed by 5 blue).All firings were completed by the logs with 0 or 1 pause for compression.The stapler instrument had two incomplete clamps on the sixth overall install and one aborted clamp on the fifth overall install, otherwise all other clamps were completed and there are no unclamp failures.The logs do not show any errors related to stapler instrument usage.A review of an image provided by the customer shows a sureform 60 stapler instrument equipped with a green sureform 60 reload, which has been fired across the stomach.In one of the images, a user interface (ui) message related to the sureform 60 stapler instrument on the universal surgical manipulator (usm) is observed, stating, "before removing, align the joint straight under visual control." due to the quality, it is difficult to determine whether there are any malformations along the staple line.However, the tissue is transected, and there does not appear to be any bleeding from the staple line.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• 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: 23609502
• Report Number: 2955842-2025-45766
• Device Sequence Number: 9258957
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)K10250416
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 48360G-10
• Device Catalogue Number: 48360G
• Device Lot Number: K10250416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown