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

Model Number 470057-08

Device Problem Material Integrity Problem (2978)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations did replicate/confirm the customer reported complaint.The endoscope was received with attached endoscope adapter (aea) damage or friction issue.The endoscope had discoloration of the ic housing.

Event Description

It was reported that during a da vinci assisted radical cystectomy with ileal conduit surgical procedure, the 0 degree endoscope plus had an image orientation issue - the image was mirrored.A backup endoscope was used to proceed with the case.The procedure was completed with no patient injury.

• 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: 17067344
• MDR Text Key: 316709312
• Report Number: 2955842-2023-15733
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: MN
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2022

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: 04/01/2022
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• 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
• Patient Sex: Male