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

Model Number 470035-02

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337728007
• Report Number: 2955842-2024-12419
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES