MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470027-34
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the 30-degree endoscope for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, 30-degree endoscope had recoverable errors.The image was distorted (mirrored) after camera was re-inserted onto the arm.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred during a prostatectomy.The image appeared inverted/mirrored.The event did not involve a reversed control on system arms, however the endoscope moved freely with uncontrolled motion.The system recognized the correct scope but with recoverable faults.The surgeon confirmed the desired orientation when endoscope was installed.The reported was unsure if an indication of the image orientation provided to the surgeon via user interface.The issue was resolved by using a backup scope to complete the procedure.The vision issue did not result in patient injury.Hospital declined to provide patient data.
Additional Manufacturer Narrative
The 30-degree endoscope has been returned and evaluated by the failure analysis (fa) team.Fa was able to reproduce and confirm the reported complaint.The focus of the endoscope was tested on a system and found to have failed the focus test at all distances on the left eye.The endoscope was placed through a friction test using a screening aid to manually rotate the adapter to detect for friction.The camera instrument adapter did not rotate properly and noises were heard during testing and confirmed as binding.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 20264114
• Report Number: 2955842-2024-19570
• Device Sequence Number: 8723309
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 470027-34
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2015
• 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: Male