MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 CURVED-TIP

Model Number	480545-06
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved-tip sureform 45 stapler instrument was analyzed and found to have the snake wrist cover torn.The tears measured roughly 0.221".The wrist cover was torn, and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the instrument.The sureform 45 green reload accessory was also returned and evaluated by the failure analysis (fa) team.The accessory was returned to isi for evaluation attached to the returned stapler instrument.There was no damage to the reload.There were no device related failures.The reload was returned fully fired.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reload was attached to an in-house golden instrument removed from the instrument without any issues on multiple attempts.No product issue was identified.The complaint was confirmed by failure analysis.The probable root cause of the torn wrist cover was attributed to the potential user mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the rubber sleeve that covers the hinge of the curved-tip sureform 45 stapler instrument bunched up and would not allow the stapler to come out.Fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional information: the surgical staff did not see anything that would reflect an issue of a fragment falling inside the patient.Routine x-rays were performed, but not specifically for "fragments." it was unknown if patient returned to the hospital due to any post-surgical complications.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 CURVED-TIP
• 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: 25090199
• Report Number: 2955842-2026-23842
• Device Sequence Number: 14710150
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K11250129
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K11250129 0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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