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

Model Number	410370-04
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer encountered a piece of a detached disposable stapler sheath.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the issue was identified during the procedure.A fragment fell inside of the patient and was retrieved during the same procedure.The customer retained the sheath fragment that had fallen into the patient and is determining the feasibility of sending it in; the customer can send the sheaths that were tested when trying to investigate/replicate the issue.There is a photograph of the retained fragment after retrieval, but the picture was taken after the fragment was removed from the sterile field, it does not show the fragment in place.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.The event investigation is in progress.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received 3 stapler sheaths to perform failure analysis.The stapler sheaths were analyzed and all 3 sheaths were found to have damage.Each stapler sheath was found to have a piece of the sheath separated from the rest.However, a visual inspection of each stapler sheath displayed no missing material.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 21316168
• Report Number: 2955842-2025-01204
• Device Sequence Number: 20942011
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)K11230921
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• 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,Followup
• Report Date (Section B): 01/09/2025

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: K11230921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White