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

Model Number	480545-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the sureform 45 curved tip stapler had a torn piece of rubber at the flexion site.The customer completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no instrument collision during the procedure.The instrument piece was not completely detached.There was no fragment fall into the patient and no injury to the patient.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The sureform 45 stapler was analyzed and found a torn wrist cover at the distal end as the primary issue, with no material loss observed.The complaint was confirmed by failure analysis.The probable root cause of the failure mode tears/torn instrument wrist cover are typically attributed to the user, such as excessive contact with abrasive or hard surfaces during use or reprocessing.

• 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: 24879014
• Report Number: 2955842-2026-21527
• Device Sequence Number: 15957429
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(17)281031(10)K15251016
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K15251016 0372
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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
• Patient Sex: Unknown