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

Model Number	470026-64
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the instrument for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.
Event or Problem Description
It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the surgeon stated the eyes on the 0-degree endoscope did not match up in the surgeon side console (ssc).The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the customer denied the occurrence of an inverted image, free movement of the endoscope with uncontrolled motion, or reversed control on the system arms.The surgeon confirmed desired orientation when the endoscope was installed, however, it could not be confirmed if an indication of the image orientation was provided to the user via the user interface.The endoscope and endoscope's adapter/base were confirmed to be engaged/in-synch/attached.The surgeon stated that the image looked like the image was overlapping or crossed eyed.The endoscope end was removed and replaced, however, the cross-eyed image still appeared.The endoscope was replaced with a new one to complete the procedure.In addition, intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The endoscope was analyzed and found to have failed the focus test due to poor focus at all distances in one of the eyes.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 0-degree 8mm endoscope was analyzed and tested on a system or equivalent and found to fail the focus test.The endoscope failed focus at a working distance in which the test failed on right eye.The endoscope was visually inspected and/or placed on in-house system and detected with a camera module issue.The camera module exhibited front negative lens detached.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to 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: 20327377
• Report Number: 2955842-2024-19945
• Device Sequence Number: 8099684
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/05/2024

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: 09/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 10/21/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/12/2024
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic