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

Model Number	371868-04
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the camera cable involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The camera cable was installed on an in-house printed circuit assembly (pca) and tested.The camera failed testing as a purple image on the right eye was observed.During visual inspection, the camera cable was found kinked and was missing the serial number.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the camera cable displayed a purple image on the surgeon side cart (ssc) and vision side cart (vsc).The customer did not have a backup or secondary camera cable available.The procedure was converted to laparoscopic surgery.Intuitive surgical, inc.(isi) followed up with the operating room (or) manager and obtained the following additional information: the patient was on the table and ports were placed when the issue occurred.The or team lost the image and attempted to troubleshoot the issue.However, the only solution was to replace the cable.Or team tried to find a spare cable in another service but could not.As surgery was already postponed due to covid-19, and they could not use the system, the surgeon decided to convert to laparoscopic surgery.The delay was approximately 1 hour and 40 minutes from the moment issue occurred to the moment they decided to convert due to the described troubleshooting steps.No post-operative complications were observed, and the patient was reported to be doing well.

• Brand Name: NONE
• Common Device Name: CAMERA HEAD CABLE
• 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: 17102458
• Report Number: 2955842-2023-16181
• Device Sequence Number: 15312022
• Product Code: NAY
• UDI-Device Identifier: 00886874110386
• UDI-Public: (01)00886874110386
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 371868-04
• Device Catalogue Number: 371868
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 06/11/2023
• 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: Unknown