MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE, FIREFLY

Model Number	370892-03
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a blurry image issue when using fluorescence endoscope, an investigation is in progress.A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, site converted to laparoscopic due to blurry right eye view.In addition, site informed that the faulty endoscope was only fluorescence endoscope and it was mandatory for this surgery, that's why procedure was converted.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the arm rotated on its own when the surgeon took control of the surgeon's console.According to the customer, it was possibly related to arm positioning.The reporter do not remember which instrument was installed on the arm.It was not an instrument issue, the instrument worked on the other arms.The defective endoscope was a 0° endoscope fluorescence: (b)(4).The surgery was an enlarged colpohysterectomy + pelvic curage performed by dr ducher.The rotation issue occurred while the surgeon's head was inside the high-resolution stereo viewer on the surgeon's console.The issue occurred while the surgeon was trying to manipulate instruments from the surgeon's console.No shakiness and/or friction felt/observed.There was no interference between the instruments or between the arms of the system.There were no external collisions.The issue was intermittent, probably related to arm positioning.The instrument arm drape has been thrown away.The operation was converted, as 1 arm was not usable and one eye of the optics was defective.The conversion did not result in an increase in the size of the incision or the addition of additional ports.The patient did tolerate the conversion.There was no patient harm nor injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and subsequent major damage to optical components.The distal window was intact, and no missing pieces were noted.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE, FIREFLY
• 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: 17359120
• Report Number: 2955842-2023-17187
• Device Sequence Number: 6912475
• Product Code: GCJ
• UDI-Device Identifier: 00886874110201
• UDI-Public: (01)00886874110201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 370892-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/28/2023
• 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: 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: Female