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

Model Number	48360B-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sureform stapler 60 blue reload has not been returned to intuitive for failure analysis.Stapler logs showed the sureform 60 stapler involved with the event was installed on the system 1 time and fired 1 blue reload.On the only install, the first 5 clamps were incomplete.The 6th clamp was successful but was followed by a firing failure.There were no stapler related errors in the logs.Additional patient demographic information: body mass index (bmi) 23.49 kg/m2 with a height of 168 cm.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) surgical procedure, the surgeon fired the sureform stapler 60 with a sureform 60 blue reload and the stapler only fired halfway.An error message appeared stating, "tissue too thick to continue.Tap blue pedal to unclamp and consider changing reload color." no error was given prior to firing stapler.The bowel tissue was firm and had been exposed to chemotherapy.There was no tissue tension or bunching.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws nor did they fire over an existing staple line.No buttress material was used.Staples fell into patient but were retrieved with robotic instruments and suction/irrigation.The was no bleeding observed on the staple line due to the stapler issue.A new stapler and load were opened.The surgeon readjusted bite and clamped again with no error.There were no issues with the new stapler.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform stapler instrument associated with this event was received and failure analysis found the instrument to have one firing failure based on log review, which was not replicated through in-house testing.The stapler was installed onto an in-house system and fired on a test foam using two in-house green reloads.The instrument fired successfully, and the resultant staple-lines were visually inspected.The cut-lines appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The reload was not returned for failure analysis.
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: 23401649
• Report Number: 2955842-2025-43203
• Device Sequence Number: 18687022
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K11250612
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: K11250612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native