• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 470179-19
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer discovered the orange part of the monopolar curved scissors (mcs) instrument shaft was broken. There was no report of any fragments falling inside the patient. The customer replaced the mcs instrument with a back-up instrument of the same kind and completed the procedure with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar curved scissors (mcs) instrument involved with this complaint and completed the device evaluation. Failure analysis investigations replicated/confirmed the customer reported complaint. Failure analysis found the primary failure of the broken tube extension to be related to the customer reported complaint. The instrument was found to have a broken tube extension where it meets the proximal clevis at the distal end. Failure analysis found a broken piece measuring roughly 0. 078¿ x 0. 193¿ in size that was not returned with the instrument. The root cause of the ¿broken instrument tube extension¿ is typically attributed to mishandling/misuse. There were additional observations not reported by the site and related to the primary failure. The instrument was found to have broken grip cables at the distal end. The root cause of this failure is attributed to mishandling/misuse. The instrument was found to have broken pitch cables at the distal end. The broken cable segments that contains the crimp was still installed in the clevis. The root cause of this failure is attributed to mishandling/misuse. The instrument was found to have a dislodged proximal clevis. The root cause of this failure is also attributed to mishandling/misuse. A review of the device logs for the monopolar curved scissors (part# 470179-19, lot-sequence# n12210125-0389) associated with this event has been performed. Per this review of the logs, the monopolar curved scissors was last used on (b)(6) 2021 during a radical extraperitoneal with lymphadenectomy prostatectomy procedure performed via system serial# (b)(4). A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the provided image was performed by an intuitive surgical, inc. (isi) failure analysis engineer (fae). The following additional information was provided: the complaint of broken shaft was confirmed. This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledged that a fragment was missing from a portion of the device that enters the patient. Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure. While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceMONOPOLAR CURVED SCISSORS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13642957
MDR Text Key296617137
Report Number2955842-2022-10421
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470179-19
Device Catalogue Number470179
Device Lot NumberN12210125 0389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Date Manufacturer Received03/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/01/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-