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

Model Number	48345B-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.A review of the stapler logs was attempted.However, a search of the logs did not return any results aligned with the product information and event date provided.Note: refer to medwatch report (mdr) with mfr.Report#: 2955842-2026-25208 and mfr.Report#: 2955842-2026-25210 for mdr submission of the event against the other blue reloads used in this procedure.
Event or Problem Description
It was reported that during an unspecified da-vinci assisted surgical procedure, an incomplete staple line was observed when three sureform 45 blue reloads were fired with sureform 45 stapler instrument.After each stapler reload was fired, only one side of the staple line had staples, leaving the intestinal lumen open.The instrument was inspected prior to use and showed no abnormalities.The stapler fires involved with the reported event were the first, second, and third.At the time the stapling issues occurred, the surgeon was working on the intestines and "settling the rectum." there was no tissue tension or tissue bunching.The stapler instrument fired without problems or interruptions.No error messages were generated when the stapling issue occurred.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The surgeon did not fire over an existing staple line.The surgeon did not experience any clamping issues prior to firing the stapler reload.No bleeding was observed on the staple line due to the stapler issue.The procedure was completed by suturing the seam or staple line by hand.The issue caused a delay of less than 15 minutes.No fragments fell inside the patient.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 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: 25189121
• Report Number: 2955842-2026-25209
• Device Sequence Number: 10543101
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)K11250612
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183224
• 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): 05/15/2026

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: 48345B-03
• Device Catalogue Number: 48345B
• Device Lot Number: K11250612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/15/2026
• 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 Sex: Unknown