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

Model Number	470067-11
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, endoscope did not change orientation.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have an attached endoscope adapter (aea) bearing friction issue.This defect was confirmed as binding.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.Further investigation confirmed additional observations.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 or broken or missing pieces located at cable connector proximal end.The root cause the damage is typically attributed to the user, such as improper reprocessing.The endoscope was visually inspected and was found with damage to the light guide ferrule.The light guide ferrule was found with melted fiber damage.The root cause of the damage is typically attributed to the user.The most common root cause is due to not fully inserting the connector to the connection port on vision side cart or inadvertent collisions with hard surfaces or drop of the scope.The endoscope was visually inspected and found with minor cut(s) to the cable insulation.The damage was located at zone b in the middle 1/3 of the endoscope cable.The root cause for the damage is typically attributed to the user, such as improper handling of the cable during use or in reprocessing.The endoscope was visually inspected and found with mechanical damage to the scope¿s distal tip.The root cause of the damage is typically attributed to the user, such as inadvertent collisions with hard surfaces or drop of the scope.The endoscope was visually inspected and found with damage to the button pack assembly.Visual inspection confirmed hairline crack(s) on illumination of the button pack assembly.The root cause of the damage is typically attributed to the user, such as inadvertent collisions with hard surfaces or drop of the scope or caused by improper cleaning during reprocessing.The endoscope was visually inspected and found with cosmetic damage.During inspection of the endoscope housing, the housing shell exhibited laser marking fading and/or removed.The root cause for the damage is typically attributed to the user, such as improper reprocessing.The endoscope cable integrated connector was visually inspected and found with scratches at trimplate.The cable integrated connector exhibited scratch marks.The root cause of the damage is typically attributed to the user, such as improper reprocessing.The endoscope was visually inspected and glue damage on fiber distal tip (gap) was found.During inspection of the endoscope distal tip, fiber damage was found.The root cause for contamination is typically attributed to the user, such as improper reprocessing.The endoscope cable integrated connector was visually inspected and found ic broken.The root cause of connector broken is attributed to the user, such as improper reprocessing.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• 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 ; +1(408)523-2100
• MDR Report Key: 50052216
• Report Number: 2955842-2026-33767
• Device Sequence Number: 10640163
• Product Code: GCJ
• UDI-Device Identifier: 00886874120286
• UDI-Public: (01)00886874120286
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 470067-11
• Device Catalogue Number: 470067
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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