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

Model Number	470026-64
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the endoscope suddenly started moving in the opposite direction in reference to the master tool manipulator movement.The customer stated that the system had been hard power cycled, and instruments were reseated, but issue persisted.Assignment of instruments were correct.Intuitive surgical, inc.(isi) technical support engineer (tse) requested the customer to replace the endoscope.After doing so, the movement returned to normal.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the reported event.However, as of the date of this report, no additional information has been provided.
Additional Manufacturer Narrative
Based on the claim against the product by the customer, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the endoscope to perform failure analysis.The endoscope was placed on in-house system for a functional testing and failed to provide a video due to an electrical communication failure.The endoscope showed color bars in both eyes.The endoscope shaft's circularity was tested using a go-no-go gauge and failed.The gauge failed to slide smoothly down scope's shaft due to damage found at tip and/or shaft.The complaint was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.Additional observation not reported by the site was also identified: the endoscope integrated connector was visually inspected and found with corrosion/damage to the electrical contacts and/or circuit board.

• 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: 17410567
• Report Number: 2955842-2023-17374
• Device Sequence Number: 8741210
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/07/2023

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: 470026-64
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/27/2023
• 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