MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ENDOSCOPE

Model Number 470056-05

Device Problems Image Orientation Incorrect (1305); Noise, Audible (3273)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer was dispatched to the customer site to further investigate the reported complaint.The reported complaint was not confirmed based on the field evaluation.There was no trouble found on the system.The system was tested and verified as ready for use.Isi has received the endoscope, but evaluation has not yet been completed.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted when the evaluation is completed and/or if additional information is obtained.A review of the instrument log for the endoscope associated with this event was performed.Per logs, the endoscope was last used on (b)(6) 2020 on system (b)(4).The endoscope had 1974 uses remaining after the last use.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: a dislodged camera adapter could result in poor camera control, which could result in unintuitive motion and subsequent tissue damage.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.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, there was non-intuitive movement on both arms of the system.The customer rebooted the system and reinstalled the sterile adapter and instruments.There was also a strange noise on the camera.It creaked loudly during rotation.The grey rotating base of the endoscope would get stuck.The customer replaced the endoscope to resolve the issue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 20-nov-2020 and obtained the following additional information: the endoscope was properly installed on the system.There were no issues noted where the endoscope shaft connected to the housing.The endoscope could no longer be rotated.When the vision issue occurred, the camera was locked in one orientation.The movements of the system were twisted by approximately 90 degrees and the operation was not intuitive.Shortly thereafter, no rotation was possible.The patient was (b)(6).It is unknown if any relevant tests were performed and there was no relevant patient history.

Manufacturer Narrative

Additional information can be found in the following sections: g3, g6, h2, h3, h6, h10.Intuitive surgical, inc.(isi) has received the endoscope involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the reported complaint.The camera instrument adapter was damaged and had a friction issue.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10909874
• MDR Text Key: 241810566
• Report Number: 2955842-2020-11272
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (y/n): N
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470056-05
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 73 YR
• Patient Weight: 85