MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; ATRIAL RETRACTOR SHORT RIGHT

Model Number	470246-09
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the atrial retractor short right (arsr) moved in an unexpected direction.The customer used a backup instrument to continue with the procedure.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.There was no fragment falling inside the patient¿s anatomy.The procedure was not delayed.The procedure was completed robotically with the same da vinci system.There was no patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the da vinci product with an alleged issue to perform failure analysis; however, the investigation is in progress.A follow-up mdr will be submitted if the product is evaluated and/or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis (fa) testing.The instrument was analyzed and the customer-reported complaint could not be replicated.Visual inspection did not reveal any damage.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly and were aligned.The instrument was fully functional.No product issue was identified.The complaint was not confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: ATRIAL RETRACTOR SHORT RIGHT
• 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: 19282894
• Report Number: 2955842-2024-14103
• Device Sequence Number: 7439635
• Product Code: NAY
• UDI-Device Identifier: 00886874112397
• UDI-Public: (01)00886874112397(11)230601(10)K10230601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: Health Professional
• Device Model Number: 470246-09
• Device Catalogue Number: 470246
• Device Lot Number: 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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