MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number	470026-64
Medical Device Problem Codes	No Display/Image (1183); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted salpingectomy surgical procedure, the endoscope instrument had a fuzzy view, and the eyes on the surgeon side console (ssc) had two separate images.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgical task being performed was a da vinci laparoscopy, bilateral salpingectomy, excision, and endometriosis, cystoscopy.The image was fuzzy and in surgeon side console (ssc) 2 there were two separate images.The endoscope did move freely with uncontrolled motions.The event did not involve a reversed control of system arms.It was a 0-degree endoscope.The surgeon did confirm the desired orientation when the endoscope was installed.There was an indication of the image orientation provided to the user via the user interface.The endoscope and endoscope¿s adapter/base are still engaged/in sync/attached.There was damage observed on the endoscope¿s adapter/base such as a missing screw(s) or component.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the part; however, failure analysis has not completed their investigation.A follow-up mdr will be submitted when failure analysis has completed their investigation.
Additional Manufacturer Narrative
The 0-degree endoscope has been evaluated by the failure analysis (fa) team.Fa was able to reproduce and confirm the reported complaint.The endoscope was visually inspected and/or placed on in-house system and fa detected a camera module issue.Additional observation not reported by site: the endoscope was evaluated and was found with a camera instrument adapter defect.The endoscope was placed through friction test using a screening aide to manually rotate the adapter to detect for friction.The camera instrument adapter did not rotate properly and/or noises were heard during testing and confirmed as binding.The camera instrument adapter removed from endoscope housing and evaluated and found with attached endoscope adapter (aea) shaft bearing contributing to friction.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18603327
• Report Number: 2955842-2024-10686
• Device Sequence Number: 13049948
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: 470026-64
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female