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

Model Number 470057-08

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci assisted surgical procedure, the endoscope plus 30 degree was observed with control that was displayed upside down during the operation.The procedure was completed with no reported injury.On may 20, 2021, intuitive surgical, inc.(isi) contacted the site to obtain additional information regarding this event.However, no additional details have been received as of the date of this report.

Manufacturer Narrative

Isi received the endoscope involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.A damaged or friction issue was noted on the camera instrument adapter.Fa also observed discoloration on the housing of the endoscope.The root cause was attributed to mishandling/misuse.No photo or video was provided by the site for review.A review of the device logs for the 30 degree endoscope (part# 470057-08 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the 30 degree endoscope was last used on (b)(6) 2022 via system serial# (b)(4).There were 1942 uses remaining after this last usage.This complaint is considered as reportable due to the following conclusion: it was alleged that the endoscope moved with unintuitive motion with no evidence or claim of user mishandling or misuse.Poor camera control could result in unintuitive motion and subsequent 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.

• 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: 14740084
• MDR Text Key: 301930910
• Report Number: 2955842-2022-12244
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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