MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE PLUS

Model Number 470057-08

Device Problem Optical Distortion (3000)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted incisional hernia surgical procedure, the 30 degree endoscope had double vision.There was 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.

Manufacturer Narrative

The 30 degree endoscope has not been returned to intuitive surgical, inc.(isi) for evaluation.If additional information is received, a follow-up mdr will be submitted.The 30 degree endoscope part# 470057-08/ lot/serial# (b)(4) was last used on (b)(6) 2022 on system (b)(4) with 1943 use remaining.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was reported that the endoscope displayed double vision.The issue was resolved through the use of a backup endoscope.Poor vision and/or camera control could result in tissue damage.At this time, the root cause of the failure is unknown.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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information found in: d9, g3, g6, h2, and h3 evaluation information found in: h6 and h10 the 30-degree endoscope has been returned and evaluated by the failure analysis team.Failure analysis could not replicate nor reproduce the reported issue.The image was good in both eyes.Sapphire distal window was found to be damaged/cracked.Camera adapter and scope had friction issues.

• Brand Name: NONE
• Type of Device: ENDOSCOPE PLUS
• 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: 15656382
• MDR Text Key: 307097366
• Report Number: 2955842-2022-14776
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191736
• 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,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-08
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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