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

Model Number 430077-01

Device Problem Output Problem (3005)

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

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the sp system utilized for the case went down.Either a plug or the firefly camera instrument would cause a fault.The clinical sales manager (csm) called the following week to report this and was not sure if the issue was with the scope or not.The field service engineer (fse) would go either that day or the next.The account was very upset at the time.They cancelled a case the previous week on friday and moved it to wednesday.If the fse noticed that there was nothing wrong with the system then the csm wanted to proactively change out their scope.The 2nd firefly camera failed closer to the end of the procedure and another camera was pulled in.The customer completed the procedure and another fault/error occurred.The procedure was completed with no reported injury.

Manufacturer Narrative

An advanced failure investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The firefly camera instrument was analyzed, and failure analysis (fa) investigations confirmed the customer reported complaint through error logs and endoscope diagnostic rest (edt) testing.Review of logs confirmed error 48221, 48225, 48229, and 48216 indicating a communication/power issue using system sp0235.The 1st edt also failed with a repeater communication test failure related to voltage.The camera was placed on the in-house system on multiple attempts and the camera passed initialization with no issues.The camera passed all the qap (quality assurance procedure) testing.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.A follow-up mdr will be submitted if additional information is obtained.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: when asked what the issue was that occurred the reported stated that the 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 it 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.When asked how the procedure was completed the reported stated that for the first procedure of the day, we had to convert from sp to xi to complete the case.For the second procedure the case was completed with a backup endoscope.However, that 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: 17703867
• MDR Text Key: 322923876
• Report Number: 2955842-2023-18269
• 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: 09/07/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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