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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER

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INTUITIVE SURGICAL, INC ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER Back to Search Results
Model Number 470230-12
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the large hem-o-lock clip applier wrist was turning without the surgeon navigating it, also the white disc is popping out. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the reporter clarified that by "white disc", they meant the input disc on housing end that is responsible for manipulation the instrument. There were no issues noted prior to use. The customer removed the instrument and completed the procedure using a spare. There was no report of patient injury. No further details/information available.
 
Manufacturer Narrative
The large hem-o-lock clip applier instrument has been returned and evaluated by the failure analysis team. Failure analysis investigations replicated/ confirmed the customer reported complaint "white disc is popping out. " but could not replicate or confirm "wrist turning without surgeon navigating it. " failure analysis found the primary failure of broken input disk to be related to the customer reported complaint. The instrument was found to have an input disk broken. Input disk # 6 was found completely detached from the base of the housing. Hairline cracks were found on grip input shafts. No damage to the distal end was observed. The root cause of this failure is attributed to mishandling/ misuse. Failure analysis found the secondary failure of failed engagement to be related to the customer reported complaint. The instrument failed mechanical engagement when placed in the system. Instrument inputs failed to engage with the sterile adapter in multiple attempts. This failure is likely due to the broken input disk observed. As a result of the failed engagement and the broken input disk, functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device. There were no engagement failures found during log review. A review of the site's complaint history does not show any additional complaints related to this product or this event. No image or procedure video was provided for review. A review of the instrument log for the large clip applier instrument (470230-12/n11200406-0208) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2021. This complaint is being reported based on the following conclusion: it was alleged that the large clip applier moved freely with uncontrolled motions with no evidence or claim of user mishandling or misuse. Poor instrument control could result in unintuitive motion and subsequent tissue damage. 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. Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
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Brand NameENDOWRIST
Type of DeviceLARGE HEM-O-LOK CLIP APPLIER
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 Key12993279
MDR Text Key285096882
Report Number2955842-2021-11735
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470230-12
Device Catalogue Number470230
Device Lot NumberN11200406 0208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
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: 12/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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