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 03/03/2020

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 reported complaint of there being no picture.The camera was placed on the in-house system and failed the quality assurance procedure test.The failure happened during initialization, and there was no image on both eyes.The failure analysis engineer reviewed pc trace and error logs.The cause of the failure was found to be due to low current reading in the printed circuit assembly board (likely due to a short).The low and high current reading were below specification, which resulted in error 48225, shown in the error log.Residual soil was found on the distal fibers of the camera.Additionally, the fibers were observed under a microscope and were found with a missing fragment of epoxy layer.Due to the transparency of the layer, it is difficult to determine the size of missing fragment.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 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's 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 fragment(s) may have fallen.Follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.

Event Description

It was reported that the single port camera had no picture.There was no reported injury to the patient.There was no reports of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) contacted the customer and obtained the following information: the issue was discovered prior to starting and the procedure was completed.The customer was not able to provide any patient information.

• 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: 10047800
• MDR Text Key: 229288130
• Report Number: 2955842-2020-10481
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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: 03/13/2020
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1