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

Model Number	470026-63
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the 0-degree endoscope had an inverted image.No further information was provided.The user continued the procedure with no reported injury.
Additional Manufacturer Narrative
Based on the claim against the product by the customer, an investigation is in progress to determine the cause of this reported event.Isi has received the endoscope involved with this complaint; however, failure analysis has not completed their investigation.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.Although the complaint has not been confirmed by failure analysis since the failure analysis is in progress, the information gathered indicates that the device did contribute to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the system was initially powered on without errors.The endoscope image was inverted, and the endoscope did not move freely with uncontrolled motion.The customer performed troubleshooting and manual calibration.The surgeon confirmed the desired orientation when the endoscope was installed, and an indication of the image orientation was provided to the user via the user interface, but nobody was aware of it.The endoscope and endoscope adapter/base were still engaged/attached, and no damage was observed on the endoscope adapter/base.It is unknown if the endoscope was manually rotated 180 degrees prior to the event, and it is unclear if the surgeon manually associated the right and left masters with the respective arms.The procedure was completed with the same endoscope, and no patient injury resulted from the vision issue.An investigation was completed to determine the cause of this reported event.Isi received the endoscope involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.The endoscope was tested and placed on an in-house system for camera cables due to an electrical failure on the endoscope cable.The endoscope was visually inspected and found to have cosmetic damage.During the inspection of the endoscope cable integrated connector, discoloration was observed.Visual inspection confirmed discoloration of the housing.

• Brand Name: NONE
• 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: 17322119
• Report Number: 2955842-2023-17049
• Device Sequence Number: 5536747
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/26/2023

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: 470026-63
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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