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

Model Number	470026-65
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.However, failure analysis is not complete.
Event or Problem Description
It was reported that the 0-degree endoscope plus was having issues with focus, and the image was drifting, it wouldn't hold in place.The customer reported event has no report of patient injury.Isi followed up but no additional information was available.
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 found to have a flickering/rolling image.The endoscope was evaluated and found with a camera instrument adapter defect.The endoscope was placed through friction test using a screening aide 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 camera instrument adapter removed from endoscope housing and evaluated and found with aea shaft bearing contributing to friction.The endoscope was visually inspected and manually tested by hand using series of movement tests and failed.The endoscope was detected with rattling or noise from the housing and/or detected loose balls from the led windows.The endoscope was disassembled and confirmed with dislodged desiccant balls inside backend housing.The probable root cause is attributed to damage during use or improper handling.Damage can result from mechanical impact, such as accidental drops of the endoscope or inadvertent collisions with hard surfaces.The probable root cause of this binding is attributed to component susceptibility to increased friction.
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: 22160240
• Report Number: 2955842-2025-22696
• Device Sequence Number: 7266142
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 470026-65
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/08/2025
• 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: Unknown