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

Model Number	48345W-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 45 stapler was unable to open.The customer was unsure if firing had occurred.The surgeon engaged the enhanced force and the tissue was stapled and cut completely.The user completed the procedure using a backup stapler with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Isi followed up with the initial reporter and obtained the following additional information: the instrument was able to staple and cut normally.There was no stapling issue.This occurred while using a white reload.The customer was able to open the jaws successfully.There was no bleeding observed and no unplanned tissue removal.The customer used a new stapler to continue the procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 white reload to perform failure analysis (fa).Related to the customer reported complaint.The reload was found to have the blade rotated within the knife track.The blade was not exposed above the surface.There was also cartridge and blade damage noted at the site of the rotated blade.Root cause of this failure is component failure.Additional observation(s) related to customer reported complaint: the reload was found to have cartridge damage.The cartridge was damaged in between the knife track at the site of the blade rotation.The reload cartridge was damaged.Visual inspection displayed signs of missing fragments.The reload blade was found to have mechanical indentations.The reload cover was removed, the shuttle was pulled forward to allow access to the knife, and the knife was inspected.Damage was found to the blade.Several other sureform 45 white reloads were also returned for fa.These reload were returned fully fired.It was not returned with an instrument.The reload cover was removed and inspected.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.No product issue was identified.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.As of the date of this report, the curved tip sureform 45 stapler has not yet been received by isi for evaluation.

• 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 ; +1(408)523-2100
• MDR Report Key: 50864019
• Report Number: 2955842-2026-39707
• Device Sequence Number: 16131212
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10260122
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: K10260122
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 127 LB
• Patient Race: White