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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST TENACULUM FORCEPS Back to Search Results
Model Number 470207-08
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported during a da vinci-assisted surgical procedure, the 8mm tenaculum forceps instrument was not recognized by the system. The procedure was completed 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 8mm tenaculum 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 failed engagement test to be related to the customer reported complaint. The tenaculum forceps instrument passed the recognition test but failed the mechanical engagement when placed on the system. The instrument inputs failed to engage with the sterile adapter in multiple attempts. A review of logs showed multiple engagement failures. An error code 22020 was observed, indicating that the installed tenaculum forceps failed to engage on the universal manipulator (usm3) (wrist pitch axis failed to engage). Failure analysis found the secondary failure of a broken pitch cable to related to the customer reported complaint. The instrument was found to have a broken pitch cable at the distal end and the broken cable segment that contains the crimp was still installed in the clevis. 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 the broken pitch cable was attributed to a component failure and related to device design. A review of the instrument log for the tenaculum forceps (470207-08/ n10170207-0028) associated with this event has been performed. Per logs, the tenaculum forceps was last used on (b)(6) 2021 on system sk2147. The alleged instrument had 3 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 last procedure was provided for review. Based on the information provided at this time, this complaint is being reported based on the failure analysis findings. A tenaculum forceps 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 inside 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.
 
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Brand NameENDOWRIST
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 Key13122988
MDR Text Key290085659
Report Number2955842-2021-11839
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470207-08
Device Catalogue Number470207
Device Lot NumberN10170217 0028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
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: 12/30/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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