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 Codes	Failure to Anastomose (1028); Sepsis (2067); Unspecified Tissue Injury (4559)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the completion of a da vinci-assisted distal gastrectomy procedure, a sureform 60 blue reload staple line had separated on the lesser curve of the stomach.The surgeon reported there were no intra-operative complications with this staple line, nor any errors with this fire.The surgeon stated the staple line appeared in good condition during the procedure.Post-operatively, the patient experienced staple line failure at the gastric closure, peritonitis, intra-abdominal sepsis, and a reoperation.The patient received a reoperation and gastric closure via open surgery on post-operative day five.During the reoperation, a 1.5 cm dehiscence of the blue reload staple line was observed on the lesser curve of the stomach along with peritonitis.The rest of the staple line and other anastomoses were observed to be intact and fine.The surgeon reported that the patient is septic and critically ill in the intensive care unit (icu).The surgeon reported the sepsis is life threatening.The surgeon said based on their observations and knowledge on this event, the cause of this complication was a staple line failure on thick, obstructed stomach tissue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the product for failure analysis evaluation.The customer provided a video of the stapling of the stomach.Viewing the video, it could not be determined why the reported event occurred.There did not appear to be any failures to clamp or any pauses during firing that would indicate that the tissue was too thick.The staple line appeared intact and hemostatic.The stapler logs for this procedure were reviewed.The logs show that the sureform 60 stapler was installed on the system 6 times and fired 6 blue reloads.On each install, all clamp attempts were successful, and the firings were each completed with no pauses for compression.There were no relevant stapler related errors in the system logs.Additional patient demographic information: height of 175.3 cm / 5' 9" with a body mass index (bmi) of 33.01 kg/m2.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 23014669
• Report Number: 2955842-2025-36865
• Device Sequence Number: 9547111
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: 48360B-10
• 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: 08/19/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White