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

Model Number	480545-04
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was found to have the snake wrist cover torn.The tears measured roughly.387"-.567".The wrist cover torn and there may be missing pieces, but the size of the missing pieces cannot be confirmed.The probable root cause can be attributed to damage during various handling points, including installation or use.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon was not able to articulate the stapler along the fissure of the lung properly.The surgeon tried to straighten the stapler for the assist to remove however the articulating joint was caught on the port cannula.Once removed, the scrub nurse inspected the stapler and noticed a tear along the black joint cover and the stapler was removed from the field and replaced with a new stapler.The procedure was completed as planned with no reported injury.No fragments fell into the patient.

• 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: 24542442
• Report Number: 2955842-2026-15474
• Device Sequence Number: 9194014
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K10250313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2026

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: 480545-04
• Device Catalogue Number: 480545
• Device Lot Number: K10250313 0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sex: Unknown