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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST CADIERE FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST CADIERE FORCEPS Back to Search Results
Model Number 471049-08
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 8mm cadiere forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the customer reported complaint. Failure analysis found the primary failure of the main tube broken to be related to the customer reported complaint. The cadiere forceps instrument was found to have a broken main tube at the distal end and piece measuring approximately 0. 441¿ x 0. 470¿ was not returned with the instrument. The instrument was found to have all grip cables and pitch cables broken at the distal end. The pitch cable is a new design an the crimp is not readily visible during failure analysis. From engineering review, the crimp will not fall out unless the grip assembly is severely damaged. There is no material missing. The 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 broken grip and pitch cable is attributed to a component failure. As a result of the main tube and cable damage, the entire distal wrist was returned completely dislodged from the instrument. Upon further inspection, the cadiere forceps instrument was found to have mechanically indentations/burrs at the grip tips, distal clevis, and proximal clevis. The root cause of the mechanical indentations/burrs is typically attribute to mishandling/misuse, such as collisions with other instruments or sharp object. Additional observation(s) not reported by site was also identified: the cadiere forceps instrument housing was removed for inspection and the instrument was found to have a dislodged flush tube guide. The backend idler pulleys and idler pulley shaft were all found to be completely dislodged from the upper chassis and loose within the housing. The root cause of dislodged flush tube, idler pulley, and pulley shaft is typically attributed to mishandling/ misuse. A review of the instrument log for the cadiere forceps instrument (471049-08/k102111170375) associated with this event has been performed. Per logs, the cadiere forceps instrument was last used in a procedure on (b)(6) 2022 on system (b)(4). The alleged instrument had 13 uses remaining after the last procedural use. A review of the site's complaint history found that there were no other complaints for this product. No image or video of the procedure was provided for review. This complaint is being reported based on the customer reported complaint. The cadiere forceps instrument reportedly stuck in the cannula. Failure analysis acknowledges 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.
 
Event Description
It was reported during a da vinci-assisted esophagectomy- transthoracic- chest anastomosis surgical procedure, the 8mm cadiere forceps instrument was stuck in the cannula. The procedure was completed as planned with no report of patient harm, adverse outcome or 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.
 
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Brand NameENDOWRIST
Type of DeviceCADIERE 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 Key13694369
MDR Text Key296848386
Report Number2955842-2022-10525
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471049-08
Device Catalogue Number471049
Device Lot NumberK10211117 0375
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
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: 03/08/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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