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

Model Number	430060-35
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CAMERA, 0°
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10926282
• Report Number: 2955842-2020-11284
• Device Sequence Number: 960470
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K173906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES