MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MONOPOLAR CURVED SCISSORS

Model Number 420179-10

Device Problems Crack (1135); Arcing (2583)

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

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the monopolar curved scissors (mcs) instrument involved with this complaint and completed the device evaluation. Failure analysis investigation replicated the reported complaint of ¿scissors dull. ¿ the instrument was placed on an in-house system and cut test was performed. The scissors did not cut cleanly through 0. 006¿ latex. The latex was snagged at the scissor tips. The blade edges were not damaged. Additionally, the instrument was found to have a broken tube extension at the distal end. A broken piece was not returned, measuring roughly 0. 23¿ x 0. 09¿ in size. Any potential fragments would have been retained by the use of the tip cover accessory. The known common cause of this failure is mishandling/misuse. Upon microscopic inspection, microcracks were found on the distal end of the main tube. There is a potential for this instrument to develop microcracks to create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. A review of the instrument log for the instrument associated with this event was performed. Per logs, the instrument was last used on (b)(6) 2019 on system (b)(4). The alleged event occurred on the 6th use of the instrument. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image/video investigation required as no image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: the monopolar curved scissors instrument was used during a da vinci assisted procedure and was identified as being a part of field action 2955842-05-16-2013-005 with failure analysis confirming microcracks on the distal end of the main tube. The customer reported complaint does not itself constitute an mdr reportable event; however, the microcracks found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) instrument scissors were dull. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter on 6/16/2020 obtained the following additional information: the event date is unknown. The procedure was completed using a backup instrument with no adverse effect or injury to the patient. The issue caused a delay of approximately 10 minutes.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 10387217
• MDR Text Key: 243723103
• Report Number: 2955842-2020-10729
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420179-10
• Device Catalogue Number: 420179
• Device Lot Number: M10130131 112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2955842-05-16-2013-005