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

Model Number 470026-64

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive , inc.(isi) received the 0 degree endoscope and performed a device evaluation.Failure analysis confirmed the reported issue and found the camera adapter/attached endoscope adapter (aea) to be dislodged.This complaint is being reported because a dislodged camera adapter and aea 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.Blank mdr fields: follow-up was attempted to confirm that there was no patient involvement or to obtain patient information.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 occurred between the endoscope's 7th and 187th usage and, therefore, had not expired.Field is blank because the product is not implantable.Information for the blank fields in e1 is not available.This report has been generated in response to fda inspectional observations dated (b)(6)2020.

Event Description

It was reported that during a central processing demonstration, when placing the magnetic cleaning tip, a wheel of a 0 degree endoscope broke off.There was no report of patient involvement.

Manufacturer Narrative

Additional information can be found in fields: h6 (patient problem code and method code) and h10: intuitive surgical, inc.(isi) followed-up with a biomedical engineer at the user facility and obtained the following additional information: the endoscope was not used for a procedure.It was taken from the box for a cleaning demonstration.There was no patient involvement.

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: 10348601
• MDR Text Key: 240426991
• Report Number: 2955842-2020-10691
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (y/n): N
• PMA/PMN Number: K171426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

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: 470026-64
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES