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

Model Number	470035-02
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the handheld camera head was found to have a crack in the lens.The device was not used on the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the handheld camera head involved with this complaint and completed the device evaluation.Failure analysis confirmed and replicated the reported issue.A visual inspection was performed, and the camera's distal window was found to be damaged.There were cracks across the window observed and a broke piece was found measuring 0.132" x 0.075".The broken piece appears to be stuck inside.The camera was placed on the in-house system and fail the qap test (quality assurance procedure).The image appears to be blurry, likely due to the damaged distal window observed.No failures found in the logs.Visual inspection was performed and part of the camera housing laser markings were found to be damaged and not legible.The camera was found to have silicone film on the paddle board of the integrated connector.Visual inspection found one of the spring fingers bent at the integrate connector.

• 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: 16971261
• Report Number: 2955842-2023-13921
• Device Sequence Number: 15087395
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: 470035-02
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/21/2023
• 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: Initial
• 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