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

Model Number	470027-64
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the 30-degree endoscope image was flipped, and only one eye was displayed.The customer replaced the endoscope to continue with the procedure.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 vision issue did not result in patient injury.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse checked the endoscope 30 deg and confirmed the issue.One side of the image was flipped.When fse rotated the base, the issue had disappeared.However, rotated the base few times, the issue occurred again.Fse replaced the endoscope.After replacement, confirmed that new endoscope worked properly.After working on this issue, the system was tested and verified.The system is ready for use.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 30-degree 8mm endoscope was analyzed and tested and placed on in-house system or equivalent for functional testing and failed to provide a video due to an electrical communication failure.The endoscope was plugged on in-house system or equivalent and provided color bars in both eyes.The endoscope was visually inspected and/or placed on in-house system and detected with a camera module issue.The endoscope was disassembled, and camera module was visually inspected for damage and/or placed on a diagnostic tester.The camera module exhibited sensor board cracked.The complaint was confirmed by failure analysis.

• 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: 20516861
• Report Number: 2955842-2024-20836
• Device Sequence Number: 15628733
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: 470027-64
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/23/2024
• 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