MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; NEEDLE DRIVER

Model Number	430006-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the needle driver instrument to be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Event or Problem Description
It was reported that during a da vinci-assisted donor nephrectomy surgical procedure, customer reported the needle driver instrument was broken.It was unknown of the procedure outcome with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was analyzed and found to have a broken chassis around the nose cover area.The broken pieces were not returned, measuring roughly 0.088¿ x 0.083¿ and 0.406" x 0.161" in size.Components adjacent to this broken chassis show damage which may indicate potential mishandling/misuse.The nose cover was dislodged is the affected adjacent component.Additional observation : the instrument was found to have the nose cover to be dislodged.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: NEEDLE DRIVER
• 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: 19338600
• Report Number: 2955842-2024-14743
• Device Sequence Number: 17976746
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)U10220922
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Other
• Device Model Number: 430006-57
• Device Catalogue Number: 430006
• Device Lot Number: U10220922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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: Prefer Not To Disclose