MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER SHEATH

Model Number	410370-04
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy, the stapler sheath installed on a curved-tip stapler 30 instrument tore.The customer confirmed that the instrument and accessory were inspected prior to use, with no damage or anything unusual noted.The issue occurred after the instrument was inserted into the thoracic cavity, rotated for vessel ligation, and then removed.Upon final removal, the wrist of the instrument was straightened.Although it was suspected that a fragment had fallen inside the patient, it could not be found upon checking.No additional surgical procedure was required to remove the fragment, and no post-operative tests were performed to check for remaining fragments.The procedure was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler sheath to perform failure analysis.The stapler sheath was analyzed and found to have damage with tears measuring approximately 0.103 to 0.115 inches.A visual inspection revealed missing material.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER SHEATH
• 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: 22734282
• Report Number: 2955842-2025-32522
• Device Sequence Number: 9306578
• Product Code: NAY
• UDI-Device Identifier: 10886874111137
• UDI-Public: (01)10886874111137(17)280131(10)K11250123
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140553
• 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
• Report Date (Section B): 07/15/2025

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: 410370-04
• Device Catalogue Number: 410370
• Device Lot Number: K11250123 0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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