• 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;DAVINCI SI TENACULUM FORCEPS

  • 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;DAVINCI SI TENACULUM FORCEPS Back to Search Results
Model Number 420207-09
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument cable was found to be damaged. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and on 14-dec-2021, obtained the following additional information: the procedure occurred on (b)(6) 2021. No other information was available.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the tenaculum forceps involved with this complaint and completed the device evaluation. Failure analysis found the primary failure of severely bent grip tips to be related to the customer reported complaint. The instrument was found to have severely bent grips. The grip tips appeared to be crossed with one another at the distal end. As a result resistance was observed during manual articulation of the grip inputs. For clarification, the grip cables did not appear to be broken or damaged. The root cause of severely bent instrument grip tips is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws. Failure analysis found a secondary failure of broken pitch cable to be related to the customer reported complaint. The instrument was found to have a broken pitch cable at the distal end. The broken cable segment that contains the crimp was still installed in the clevis. Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material. The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics. Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure. The root cause of the broken pitch cable is attributed to a component failure and related to device design. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or procedure video was provided for review. A review of the instrument log for the tenaculum forceps instrument (part# 420207-09/lot# (b)(4)) associated with this event has been performed. Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system sh0350. The instrument had 6 remaining usable lives with no subsequent use recorded. This complaint is being reported because this instrument is designed with two pitch cables each with a crimp at the distal end. If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date in section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Fields are not applicable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST;DAVINCI SI
Type of DeviceTENACULUM FORCEPS
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 Key13102785
MDR Text Key284864393
Report Number2955842-2021-11830
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050369
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
Report Date 12/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420207-09
Device Catalogue Number420207
Device Lot NumberN10190715 409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Date Manufacturer Received12/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2019
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: 12/29/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-