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

Model Number 430060-33

Device Problem Material Separation (1562)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate/confirm the customer reported complaint.The camera was placed on the in-house system.The camera passed initialization with no issues.No error message was observed.The camera passed all the qap (quality assurance procedure) testing.Review of the logs did not show any failures.Additional observations not reported by the site were also identified.The leak test was performed and failed.Upon visual inspection, the camera was found to have the snorkel detached from the manifold port.This failure likely caused the failed leak test observed during in-house testing.The root cause of this failure is attributed to the user.The camera was found to have damage on the distal fibers.Residual soil was found on the distal fibers.The root cause of this failure is attributed to the user.The camera was found to have bearing corrosion when the housing was removed.The root cause of this failure is attributed to the user.The camera was tested using edt and failed.The camera failed the rct-vcl current and testexecutionstatus repeater communication tests.The root cause of this failure is not determinable.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.Verification of the event details cannot be performed via system logs because system logs were not available.No image or procedure video were provided for review.This complaint is deemed a reportable malfunction due to the following conclusion: the sp camera instrument was tested and found to have residual soil and damage on the distal fibers.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur due to the possibility of a fragment falling inside a patient.

Event Description

It was reported that prior to starting a da vinci-assisted surgical procedure, the camera instrument was observed to have had an error code when plugged in.A backup camera of the same kind was used, and the procedure was completed with no reported injury.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.

• 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: 14053702
• MDR Text Key: 298490301
• Report Number: 2955842-2022-10942
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430060-33
• Device Catalogue Number: 430060
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: ISIFA2019-08-R
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES