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

Model Number 470057-08

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the endoscope looks burned on the side.No known impact or patient consequence was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the 30-degree plus endoscope to perform failure analysis; however, the evaluation is not yet complete.A follow-up mdr will be submitted once the product is evaluated and/ or if additional information is received.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endoscope to perform failure analysis.The endoscope was analyzed and found with minor cuts to the cable insulation.The damage was located near the endoscope housing.The endoscope cable integrated connector was visually inspected and found with mechanical damage.The cable-integrated connector paddleboard exhibited mechanical damages such as scratch marks, indentations, or broken or missing pieces located at the cable's proximal end.The endoscope was evaluated and found with a camera instrument adapter defect.The endoscope was placed through a friction test, and the camera instrument adapter did not rotate properly and/or noises were heard during testing and confirmed as binding.The camera instrument adapter was removed from the endoscope housing and evaluated and found with an endoscope adapter shaft bearing contributing to friction.The endoscope was also found with damage to the button pack assembly.A visual inspection confirmed hairline cracks on the enter button lamp of the button pack assembly.Furthermore, the endoscope was found with cosmetic damage.During an inspection of the endoscope cable integrated connector, the cable integrated connector housing exhibited discoloration.

• 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: 18762445
• MDR Text Key: 336027828
• Report Number: 2955842-2024-11529
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/13/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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