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

Model Number	480545-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated sections: b2, g3, g6, h2, h6, h11.Additional information: additional information from the surgeon indicated that hemostasis was successfully achieved with compression.Once the patient was stabilized, an "anterior arm lift" approach was attempted; however, the pulmonary lobectomy procedure was converted to an open thoracotomy.The exact volume of blood loss is unknown, but the patient required a 900 ml blood transfusion.The event was attributed to a technical error during an attempt to align the stapler instrument with the vessel; the cadiere forceps instrument was inadvertently activated instead, resulting in an injury and bleeding.The patient was discharged one week postoperatively and has since recovered, with no anticipated long-term complications.It was noted that the system was running normally and was not the direct cause of this issue.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
There was no report of any malfunction of an intuitive surgical, inc.(isi) system, instrument or accessory occurring during the procedure; therefore, no product is expected to be returned for evaluation.A review of the stapler log shows that sureform 45 curved-tip stapler instrument, (lot number: k12250508-0244), was installed on the system 3 times and fired 1 sureform 45 black reload.On installs 1 and 3, a white stapler reload was installed; however, no clamping or firing was attempted.On install 2, the first clamp was successful, and the firing was completed with no pauses for compression.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the range of motion was misjudged while using a sureform 45 curved-tip stapler with a sureform 45 black reload, resulting in injury to the pulmonary vein and subsequent bleeding.This necessitated a conversion to open surgery to achieve hemostasis, after which the procedure was completed successfully.Details regarding what surgical task was being performed at the time of the event, blood loss volume, hemostasis techniques, and any additional medical interventions remain unknown.The surgeon does not believe that a da vinci system, instrument, or accessory caused or contributed to the reported event.Additional information has been requested; however, no response has been received.

• 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: 25225242
• Report Number: 2955842-2026-25514
• Device Sequence Number: 9792692
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K12250508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K12250508 0244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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; Hospitalization
• Patient Sex: Unknown