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

Model Number 372010-02

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endoscope associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue as the endoscope was received with missing distal window resulting in fluid invasion and subsequent major damage to optical components.The scope window was completely missing and fragments of adhesive of the distal window were also missing.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the lens on distal tip of the endoscope was missing.The site reported that the "mirrors might not be in proper orientation" and that there appeared to be some damage on right the side.The procedure was completed with no reported injury.

• Brand Name: NONE
• Type of Device: ENDOSCOPE
• 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: 16971263
• MDR Text Key: 315765983
• Report Number: 2955842-2023-13923
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874110447
• UDI-Public: (01)00886874110447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/30/2021

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: 372010-02
• Device Catalogue Number: 372010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES