MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOSCOPE; N/A

Model Number	470655-01
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the endoscope for evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the customer smelled a burning smell and noticed that the handheld camera was in a separate drape and had burnt through the drape.They stated that the camera and the lightguide were detached but the light guide had a red light coming out of it.The light was red possible being shined through a blue drape.The customer stated they turned off the light source when they got done using it prior to putting it in a drape.The light source was attached to the scope portion of the handheld the entire time.It was stated either they bumped the camera button for turning on the light source or they forgot to turn the light source off when they put it in the drape.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the light guide was placed into a pocket on the drape when the incident occurred.
Additional Manufacturer Narrative
The handheld camera was analyzed by the original equipment manufacturer (oem) and the complaint was not confirmed by failure analysis.There were no issues found upon inspection of the device.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOSCOPE
• Common Device Name: N/A
• 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: 20390072
• Report Number: 2955842-2024-20202
• Device Sequence Number: 6549281
• Product Code: NAY
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 470655-01
• Device Catalogue Number: 470655
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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