MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; HANDHELD CAMERA HEAD

Model Number	470035-02
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the handheld camera head was smoking.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The handheld camera accessory was analyzed, and the complaint was not confirmed by failure analysis.Failure analysis investigations did not replicate nor confirm the customer reported complaint of "smoking".The camera was placed on the in-house system, and the camera passed initialization with no issues.The camera passed all the qap (quality assurance procedure) testing.No smoke was observed to be coming from the endoscope during in-house testing.Additional observation: the entire length of the camera cable appeared to be wrinkled and deformed.

• Brand Name: DA VINCI
• 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: 18909513
• Report Number: 2955842-2024-12419
• Device Sequence Number: 12485957
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 02/22/2024

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
• Date Returned to Manufacturer: 03/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/14/2024
• 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: Unknown