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

Model Number 470027-65

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 30 degree endoscope and performed a device evaluation.Failure analysis did not confirm or replicate the reported issue, but found the attached endoscope adapter to be missing.This complaint is being reported because a missing 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.Follow-up was attempted to confirm that there was no patient involvement or to obtain patient information for sections a and b if a patient was involved.As of the date of this report, no additional information has been obtained.Device expiration date was left blank as this endoscope has 2,000 lives, which are tracked by the da vinci surgical system.This reported issue before what would have been endoscope's 205th usage and, therefore, had not expired.This report has been generated in response to fda inspectional observations dated 06-mar-2020.

Event Description

It was reported that prior to the start (during system setup) of a da vinci-assisted surgical procedure, a 30 degree endoscope's light was dim when plugged in.It was reported that the endoscope was not used on the patient.

Manufacturer Narrative

Refer to the following fields for updated information: g4, g2, h7.Please see section h6 (method) and field h10 for additional information.Intuitive surgical, inc.(isi) followed-up with the initial reporter, who indicated that patient demographic information is not available.The initial reporter corroborated the information initially reported to isi regarding the event.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10348697
• MDR Text Key: 240426843
• Report Number: 2955842-2020-10696
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (y/n): N
• PMA/PMN Number: K171426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470027-65
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES