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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST MONOPOLAR CURVED SCISSORS Back to Search Results
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.
 
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Brand NameENDOWRIST
Type of DeviceMONOPOLAR 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 Key10387217
MDR Text Key243723103
Report Number2955842-2020-10729
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
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 Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420179-10
Device Catalogue Number420179
Device Lot NumberM10130131 112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2955842-05-16-2013-005

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