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

Model Number	470026-64
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure that, the endoscope did not respond to the surgeons' controls; and the horizon was not correct and would not correct.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made a follow-up attempt to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting did not respond to the surgeons' controls, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has received the zero degree endoscope, however, failure analysis has not completed their investigation.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.
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 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.In addition, the endoscope was noted with a physical damage on the shaft.

• 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: 17330140
• Report Number: 2955842-2023-17082
• Device Sequence Number: 17729254
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/22/2023

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: 06/29/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Weight: 22 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White