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

Model Number	48345G-03
Medical Device Problem Codes	Failure to Form Staple (2579); Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted esophagectomy procedure, the sureform 45 stapler instrument equipped with a sureform 45 green reload produced an incomplete staple line.The initial two firings, utilizing sureform 45 white reloads, were completed successfully.The third firing, with the first sureform 45 green reload, also deployed without issue.However, during the fourth firing with the second sureform 45 green reload, the stapler instrument got stuck on tissue, resulting in an incomplete staple line and failure to achieve complete closure of the staple line.The affected staple line exhibited torn tissue and incomplete staple formation.The surgeon switched to a second sureform 45 stapler instrument and fired another sureform 45 green reload; however, the same issue persisted.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received four unused sureform 45 green reloads from the same lot, associated with this complaint.Failure analysis did not confirm the reported event.There was no damage to the reloads.There are no device related failures.A review of the stapler log showed that a sureform 45 stapler instrument (part #480445-06, lot #k11250828-0278) was used first, and it was installed on the system 7 times and fired 6 sureform 45 reloads (2 white, followed by 4 green).On install 1, the first clamp was incomplete.No firing was attempted on this install.On installs 2-7, all clamps were successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used again in the procedure.Next, the logs show a second sureform 45 stapler instrument (lot #k11250806-0170) was installed on the system 8 times and fired 8 sureform 45 reloads (5 green, 1 white, 2 green, in that order).On each install, the first clamp was successful, and the firings were each 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.Note: refer to medwatch report (mdr) with mfr.Report #2955842-2025-47914 for mdr submission of the reoccurrence of the stapling issue involving another sureform 45 green reload.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GREEN
• 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: 23760315
• Report Number: 2955842-2025-47912
• Device Sequence Number: 18662016
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)U10250606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 12/09/2025

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: 48345G-03
• Device Catalogue Number: 48345G
• Device Lot Number: U10250606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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