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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI VESSEL SEALER

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI VESSEL SEALER Back to Search Results
Model Number 410322-05
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the vessel sealer instrument involved with this complaint, and completed the device evaluation. Failure analysis (fa) investigation confirmed and replicated the reported complaint. The instrument was installed on an in-house system. The instrument passed the self-test, however, the instrument¿s grips would not open. The instrument was transferred to advanced failure analysis (afa) for further investigation. Afa confirmed that the instrument¿s grips would not open. The grip knob did not turn the grips, and appeared to be locked at a hard stop. The instrument housing was removed, and by turning the screw drive output shaft, the jaws were able to be opened. This indicated that the over-mold nut (a potential root cause of the instrument's jaws becoming shut) was not defective, indicating that the reported issue was caused by another component. The instrument was disassembled, and there was no evidence of stripping or jumping in the grip planetary gear set. Upon further disassembly of the instrument, the clutch sub assembly was found to be slipping. The clutch assembly intermittently failed to engage. Based on the log review, the component failed during use, indicating the issue could be intermittent in nature. The clutch assembly slipped during grip, and subsequently locking the grips closed. Afa concluded that this failure is likely related to a workmanship issue within the clutch assembly because the slipping failure was replicated on another instrument when one of the slugs within the clutch assembly was placed backward. Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event. Image/video review: no image or video clip for the reported event was submitted for review. System log review: the advanced failure analysis (afa) team reviewed the instrument log as a part of the failure analysis investigation. The log review confirmed that the vessel sealer instrument failed during use. This complaint is reportable due to the following conclusion: the endo-wrist one vessel sealer instrument¿s grips did not open and/or were clamped, and could not be opened with the use of the emergency grip release mechanism because of a possible workmanship issue. 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 patient information was either unknown, unavailable, not provided, or not applicable. The product is not implantable.
 
Event Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the vessel sealer instrument¿s jaws could not be opened. No tissue was stuck within the jaws of the instrument. The customer used a backup vessel sealer instrument to continue. The procedure was completed with no report of patient harm, injury, or adverse outcome. Intuitive surgical, inc. (isi) followed-up with the initial reporter, and received the following additional information: the surgeon was able to use the instrument once, and then the reported issue occurred before he could use it for another seal cycle. It was confirmed that there was no tissue in the jaws of the instrument at the time of the reported issue.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceVESSEL SEALER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10709596
MDR Text Key212291115
Report Number2955842-2020-11105
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110639
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410322-05
Device Catalogue Number410322
Device Lot NumberM90200217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/21/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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