MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number 430077-01

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the firefly camera instrument and performed failure analysis.The firefly camera instrument was analyzed, and failure analysis investigations confirmed through error logs the customer reported complaint.A review of logs confirmed loss of vision errors occurred on system.Logs also showed that a frozen video displayed error occurred.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.Also, no loss of image or vision issues occurred, and proper image remained at all times during in-house testing.

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, an unspecified fault occurred during attempted use of a firefly camera instrument.According to the initial reporter, the procedure was aborted after anesthesia was administered to the patient and ports were placed.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

The firefly camera instrument was evaluated by the advanced failure analysis.This return material authorization (rma) was returned along with other rma and went through similar testing by engineering.The reported issue of faulty endoscope was not replicated.The endoscope was tested on an internal system with the same software as sp0235 and with the returned endoscope controller (ec), but no issue was observed.The endoscope was fully functional.Review of the error logs showed 45310 and 45311 errors were recorded for vision loss and multiple 48229 errors with p2 value of 9, which is overcurrent on the vcl.This could potentially be related to moisture.The endoscope passed both endoscope diagnostic testing (edt), which indicated no moisture was present during internal testing.The following additional information was also obtained from follow up with initial reporter: the reporter stated that the firefly camera image began to flicker, with vertical lines appearing on the screen.It then proceeded to fail completely, leaving color bars on the screen.After unplugging the camera and cleaning the connector, the camera would fail to initialize when plugged back in.During one of the attempts, the surgical image appeared for a minute or so before the camera flickered again and shut off.It was reported that the same issue occurred with both scopes.No fragment fell into the patient.The procedure was completed.The reporter stated that for the first procedure of the day, they had to convert from sp to xi to complete the case.For the second procedure, the case was completed with a backup endoscope.However, the backup endoscope did fail upon completion of the case.There was no report of patient injury as a result of the endoscope issue.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Type of Device: CAMERA, 0°
• 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: 17714725
• MDR Text Key: 323005270
• Report Number: 2955842-2023-18331
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430077-01
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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
• Patient Sex: Male