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

Model Number 470057-08

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis (fa).Fa was able to confirm the reported complaint and found the 30-degree endoscope was missing screw/disc at the camera instrument adapter (ciad).Fa also found the paddleboard had mechanical damage, the housing was discolored, and the transmittance test failed.

Event Description

It was reported that during central processing, the 30-degree endoscope had a damaged connector.There was no report of patient involvement and no reported 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: 18260852
• MDR Text Key: 330247977
• Report Number: 2955842-2023-20887
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 11/08/2023
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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