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

Model Number 430060-35

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

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

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endowrist sp camera involved with this complaint, and completed the device evaluation.Failure analysis confirmed the following customer reported complaint "distal tip inspection failure".For clarification, the camera was inspected, found the distal fiber epoxy to be broken, and dark spots at the distal tip.Additional findings not reported by the site: the distal window was found to be damaged with scratches.The cable light guide ferrule which is located at the connector was found to have water stains.The camera was placed on the in-house system and the camera failed during initialization, giving a communication error, and a temperature sensor error.A log review was performed as part of the failure analysis investigations, and related errors were identified.No image, or video was provided for review.No other complaints related to this event were reported.Based on the additional information provided at this time, this complaint is being reported due to the following: if an endoscope with a compromised epoxy layer is used on the patient, epoxy fragments could fall inside the patient.The endowrist sp camera distal tip was re-inspected and determined to have a piece of epoxy layer missing over the distal end fibers.At this time, it is unknown when the epoxy fragments may have fallen.While there was no harm, or injury to the patient, the reported failure mode could potentially cause, or contribute to an adverse event if it were to recur.

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the endowrist single port (sp) camera failed distal tip inspection.The endoscope was replaced, and the issue was resolved.The procedure was being completed as planned with no reported injury.

• 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: 10926282
• MDR Text Key: 218976672
• Report Number: 2955842-2020-11284
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K173906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430060-35
• Device Catalogue Number: 430060
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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