MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; BLUNT OBTURATOR

Model Number	470008-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the obturator accessory was in the central sterile services department (cssd) and the customer noticed that it was loose and the blunt tip was not attached anymore.The accessory was discovered to be broken.The procedure was completed with no reported injury.Isi followed up with the customer and obtained the following additional information: the tip of the obturator was confirmed to be completely detached.No fragments were observed to be broken off or detached from the tip.There was no report of fragments falling from the device when last used within the patient.The customer was unable to release patient demographics and patient-related information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The obturator was analyzed and the shaft was found to be broken at the base of the handle.The top of the shaft measuring approximately 0.341" in diameter was returned.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: BLUNT OBTURATOR
• 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: 21692505
• Report Number: 2955842-2025-11405
• Device Sequence Number: 8730999
• Product Code: NAY
• UDI-Device Identifier: 00886874112175
• UDI-Public: (01)00886874112175(10)SA203702
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131861
• 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): 03/03/2025

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: 470008-07
• Device Catalogue Number: 470008
• Device Lot Number: SA203702
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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: Unknown