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

Model Number	470035-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested the site to return the da vinci product involved in this complaint to perform failure analysis.At the time of this report, the product has not been received.A follow-up mdr will be submitted if additional information is obtained.
Event or Problem Description
It was reported that during central processing, a piece of the handheld camera head accessory was broken off.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The handheld camera head was analyzed and was found to have a broken integrated connector light guide holder.The light guide holder legs and a corner of the light guide hand grip were broken.The returning spring was not returned with the camera.The camera was placed on the in-house system for the qap (quality assurance procedure) test and failed for a dead pixel.During testing on the in-house system, the camera exhibited a dead pixel in the center region of the image.The image was well-lit, focused, and white-balanced successfully.A review of the logs showed no errors.Additionally, the camera was found to have illegible pad printing on the housing and illegible laser marks on the cable-integrated connector.The camera was found to have dislodged camera cables.The camera cables exhibited delamination at the cable bend protection overmold.The bend protection overmold located where the cable assembly meets the housing was found delaminated.The dead pixel is the cause of the failed qap test.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: HANDHELD CAMERA HEAD
• 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: 20113845
• Report Number: 2955842-2024-18963
• Device Sequence Number: 7286723
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/12/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/31/2024
• Supplement Report FDA Received Date: 10/19/2024
• 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: Prefer Not To Disclose