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

Model Number	48345W-02
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc (isi) did not receive a da vinci product to perform failure analysis.Stapler logs showed the sureform 45 stapler was installed on the system 2 times and fired 2 white reloads.On each install, the first clamp was successful, and the firings were completed with no pauses for compression.The instrument was then 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 nephrectomy surgical procedure, the staple line of a sureform 45 white reload was incomplete, requiring an additional staple line to repair the defect.The procedure was completed robotically.Intuitive surgical, inc.(isi) has attempted to obtain additional information; however, as of the date of this report, no further details have been received.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the white sureform 45 reload associated with this complaint.Failure analysis did not confirm the reported event.The reload was returned used and fired.It was not returned with an instrument.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The cover was removed, and the reload was inspected.There was no damage to the reload or its components.No product issue was identified.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional information: intuitive surgical inc.(isi) received the sureform 45 stapler associated with this complaint.Failure analysis did not confirm the reported event.The instrument was placed on an in-house system.The instrument passed recognition and engagement.The instrument clamped, fired, and unclamped successfully.No product issue was found.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD WHITE
• 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: 22759269
• Report Number: 2955842-2025-33610
• Device Sequence Number: 9447128
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10230928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• 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,Followup
• Report Date (Section B): 07/14/2025

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: 48345W-02
• Device Catalogue Number: 48345W
• Device Lot Number: K10230928
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 08/26/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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