MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number 430077-02

Device Problem Unintended System Motion (1430)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the sp camera for failure analysis.Investigation confirmed the issue.The sp camera was placed on an in-house system and exhibited imprecise motion.The sp camera deviated slightly on one side when achieving cobra position.No deviation occurred when achieving straightened position.No obvious signs of damage to the main shaft or bellows.The camera was tested using edt (endoscope diagnostic test) and passed specification.Review of the system logs confirmed no related error fault.

Event Description

After completing a da vinci sp-assisted surgical procedure, the user observed that the sp camera shifted to the left instead of being centered in the cobra position.No known impact or patient consequence was reported.

Manufacturer Narrative

Further evaluation of the sp firefly camera endoscope was performed by the engineering team.The endoscope passed the endoscope diagnostic test (edt) and the instrument performance test (ipt).The ipt tests the range of motion specifications for the endoscope.The customer reported motion was not replicated/confirmed.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Type of Device: CAMERA, 0°
• 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: 18187764
• MDR Text Key: 328796038
• Report Number: 2955842-2023-20517
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00886874122228
• UDI-Public: (01)00886874122228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212101
• 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: 10/30/2023

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: 430077-02
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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