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

Model Number 430060-33

Device Problems Degraded (1153); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Isi received the endowrist sp camera involved with this complaint and completed the device evaluation.Failure analysis identified residual soil adhered to the tip of the camera and noted that there appeared to be a piece of epoxy layer missing over the distal end fibers of the instrument.The adhered soil is due to the interaction with degraded, inert epoxy covering the fiber optic surfaces at the tip of the camera.Based on the information provided at this time, this complaint is being reported due to the following: the endowrist sp camera instrument was found to have a piece of epoxy layer missing over the distal end fibers and it is unknown whether epoxy fragments may have fallen into a patient.

Event Description

The endowrist sp camera was returned to intuitive surgical, inc.(isi) via the rma process and failure analysis was completed on (b)(6) 2019.Although the site did not express any complaint or concern regarding the instrument, failure analysis identified residual soil adhered to the tip of the camera and noted that there appeared to be a piece of epoxy layer missing over the distal end fibers of the instrument.Although there was no report that any residual soil made contact with a patient, this mdr is being reported because of the potential for a small piece of inert, benign-geometry epoxy to be retained inside a patient.

• Brand Name: ENDOWRIST SP
• Type of Device: CAMERA, 0°
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9193917
• MDR Text Key: 199468895
• Report Number: 2955842-2019-10814
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430060-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: ISIFA2019-08-R
• Patient Sequence Number: 1