MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HANDHELD CAMERA HEAD

Model Number	470035-02
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handheld camera will not show a picture and there was a black screen.The procedure was converted to another dv system with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts 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 not show a picture and there was a black screen, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The handheld camera accessory was analyzed and found to confirm the customer reported complaint.Failure analysis found the primary failure of failed button functionality to be related to the customer reported complaint.The camera was placed on the in-house system and failed the qap (quality assurance procedure) during the set-up step.The camera illuminator was not able to turn on using the button on the camera head and it was showing a dark image.The illuminator was turned on using the screen of the vision cart and white balance was performed.The white balance and picture taking buttons were tested multiple times with no issues.Log files are unavailable.The root cause of this failure is not determinable at this time.Additional observation not reported by site: upon visual inspection, the camera cable exhibited silicone film on the contacts.The root cause of this failure is typically attributed to the mishandling/misuse.The complaint regarding not show a picture and there was a black screen was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted after the start of the procedure due to the camera not working.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The handheld camera head was transferred to the advanced failure analysis (afa) team member to identify the root cause for the button functionality issue.Afa replicated the failure on system testing; the camera was placed on system and illumination button did not work.Afa disassembled the camera and re-adjusted the button pcb board.After re-adjusting the board, the illumination button was working properly.The root cause is likely due to pcb board was dislodged after extensive use.

• Brand Name: NONE
• Common Device Name: HANDHELD CAMERA HEAD
• 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: 16641357
• Report Number: 2955842-2023-11636
• Device Sequence Number: 14964588
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191043
• 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): 03/03/2023
• 2 Devices were Involved in the Event: 1 2

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: 470035-02
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• 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