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

Model Number	470027-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 30 degree endoscope involved with this complaint to perform failure analysis (fa) testing and the fa is still in progress.
Event or Problem Description
It was reported that during a da vinci-assisted bilateral inguinal hernia surgical procedure, the 30-degree endoscope plus did not follow commands.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 endoscope moved in an unexpected or reversed direction.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and 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 the binding is attributed to component susceptibility to increased friction.Additional observation(s) not reported by site: the endoscope shaft's circularity was tested using a go-no-go gauge an failed.The gauge failed to slide smoothly down scope's shaft due to damage found at tip and/or shaft.The root cause of functional test failed: go no go gage is typically attributed to the user, such as inadvertent collisions with hard surfaces or drop of the scope.Shell housing scratch marks.The endoscope was visually inspected and found with damage to the button pack assembly.Visual inspection confirmed hairline crack(s) on all buttons of the button pack assembly.The root cause of camera button pack cracked button is typically attributed to the user, such as inadvertent collisions with hard surfaces or drop of the scope or cause by improper cleaning during reprocessing.Cracks or holes in silicone around circuit board.Glue damage on fiber distal tip (gap).Oily stain le/re.The endoscope was visually inspected and confirmed to have damage to cable assembly.The distal over-molded section of cable assembly locate at zone a near the ic housing of the endoscope cable was found delaminated.The probable root cause is attributed to adhesive susceptibility to damage through external collisions, during use, or during reprocessing.The complaint was confirmed by failure analysis.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.The probable root cause is attributed to component susceptibility to increased friction.

• 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: 22248277
• Report Number: 2955842-2025-25585
• Device Sequence Number: 21342842
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 470027-62
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2017
• 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