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

Model Number	470067-13
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the camera slipped and was upside down in the surgeon console.They had to undock the robot and re-dock to reset it.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and the reported issue was confirmed, but not replicated.The endoscope cable integrated connector was visually inspected and found with mechanical damage.The cable integrated connector ferrule exhibited mechanical damages such as scratch marks, indentations, broken or missing pieces located at the cable connector proximal end.The root cause of cable connector ferrule mechanical damage is typically attributed to the user, such as improper reprocessing.The endoscope cable integrated connector was visually inspected and found to have damage.The root cause of scratch marks or abrasions on the cable connector is typically attributed to the user, such as inadvertent collisions with hard surfaces or dropping the scope.The camera cable was visually inspected and it was found with cosmetic defects.During inspection on camera cable trim plate, water marks were found.The root cause for trim plate marks is not determinable.The endoscope housing was visually inspected and found with costumer labels/marks.During inspection of the endoscope housing, the housing exhibited customer labels or marking added, which is typically attributed to the user.The endoscope was visually inspected and found with damage to the button pack assembly.Visual inspection confirmed hairline crack on lamp button exhibiting damage of the button pack assembly, which is typically attributed to the user.The endoscope was visually inspected and was found with damage at the distal end.The distal window located at distal tip was visually inspected and found cracked, which is typically attributed to the user.The endoscope was placed through friction test using a screening aid 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 probable root cause of this binding is attributed to component susceptibility to increased friction.The endoscope cable integrated connector was visually inspected and found with corrosion on start pca.The customer system logs were reviewed, which confirmed error 48402 (camera_err_tip_temp_error).This error is related to the temperature of the camera tip having reached the error limit.This may also be accompanied by a user interface (ui) message on the display.The endoscope was connected to an afa test fixture and tested for electrical/communication continuity; the result was that endoscope did not show image in both eyes.The endoscope was tested after changed camera cables for a known good camera cables into a test fixture, then a functional test was performed to verify electrical/communication performance, which confirmed restored vision in both eyes.The endoscope was installed onto a test fixture and functional tests were performed to verify electrical/communication performance, which passed.The camera module integrity was tested by applying heat to the distal tip ~55° c and lower voltage ~1.3v to ~1.2v and the result was that camera module, and it passed.The integrated connector was disassembled for visual inspection and corrosion/damage on start pca welding conn to rx coil was found, which may have caused the failure.The endoscope was tested after changing start pca for a known good start pca onto test fixture.A functional test was performed to verify electrical/communication performance, which confirmed restored vision in both eyes.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: 25610312
• Report Number: 2955842-2026-29729
• Device Sequence Number: 9914513
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 470067-13
• Device Catalogue Number: 470067
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: Initial
• 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: Unknown