MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230W-06
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the white sureform 30 reload or sureform 30 stapler instrument for failure analysis evaluation.A stapler log review revealed the following: a sureform 30 curved-tip stapler instrument used first and installed intermittently on the system 3 times and fired 3 white sureform 30 reloads.On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.After the 3rd install, the instrument was removed and not used in the procedure again.The logs also show a sureform 45 stapler instrument was installed intermittently on the system 4 times and fired 4 sureform 45 reloads (2 blue, followed by 2 green).On each install, the first clamp was successful, and the firings were each completed with no pauses for compression.After the 4th install, the instrument was removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the staple line bled where a white sureform 30 reload was fired with a sureform 30 curved-tip stapler instrument.The target anatomy was a branch of the pulmonary artery.The firing sequence was completed without any errors and the staple line initially appeared to be intact.However, it was then identified in the middle of the staple line that there were unformed staples, and bleeding was produced from the midline.A clip was attempted to be used to address the bleeding, but was unsuccessful.A raytec sponge was then held against the bleeding staple line for approximately 15 minutes, which resolved the bleeding.The same sureform 30 curved-tip stapler instrument was used for the remainder of the procedure which was completed robotically with no further complications.The patient is reported to be recovering well.
Additional Manufacturer Narrative
A review of the video clip was conducted by a clinical development engineer (cde) / failure analysis engineer (fae) and the following statement was provided: "from reviewing the video, i can confirm that at 00:37 the stapler instrument was firing on the vessel.Once after firing was complete and surgeon unclamps the instrument (00:39), bleeding occurs from the target tissue and the surgeon grasps the bleeding vessel with the cadiere instrument.There were no error messages on the arm pod or pauses for compression and white is an appropriate reload color for vascular tissue.".
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 22460135
• Report Number: 2955842-2025-26607
• Device Sequence Number: 18287398
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K10250212
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• 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,Followup
• Report Date (Section B): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48230W-06
• Device Catalogue Number: 48230W
• Device Lot Number: K10250212
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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: Female