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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND

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INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND Back to Search Results
Model Number 480422-01
Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/05/2022
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the cause of the customer reported failure mode and intra-operative complication is unknown. Isi has attempted to contact the site to gather additional information regarding the patient/incident. However, as of the date of this report, no new information has been obtained. Isi has not received the vse instrument involved with this complaint. Therefore, the root cause of the alleged customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A system log review was performed for system sk1462 with an event/procedure date of (b)(6) 2022 as provided by the customer. Per the system logs, there is no evidence that a vse instrument with lot #m90210803-0803 was used at the site on (b)(6) 2022 or any other date. Per additional review of the system logs by an isi advanced failure analysis engineer (fae), the following was noted: there were no errors recorded that suggest an instrument failure. There was no record of a blade exposed, blade jam, or e-stop removal of the instrument on (b)(6) 2022. The only messages recorded were two ¿high initial starting impedance¿ in the e-100 logs, which are clinical-use related messages that suggest the impedance of the tissue between the jaws was higher than expected by the generator, potentially due to amount of tissue in the jaws, tissue type, or tissue dryness. No image or video clip for the reported event was submitted for review. This complaint is a reportable adverse event and malfunction due to the following: during a da vinci-assisted apr procedure, as the surgeon was trying to seal and cut mesocolon, the jaws of the vse instrument got "stuck" and a blade might be exposed message was reportedly generated. Laparoscopic forceps were placed at the two ends of the vessel and the instrument was removed forcefully. Additionally, it was alleged that the instrument issue contributed to a blood loss of 150 ml. The causes of the alleged instrument issue and bleeding are unknown. The procedure was completed with a backup vse instrument.
 
Event Description
It was reported that during a da vinci-assisted abdominoperineal resection (apr) procedure, the jaws of the vessel sealer extend (vse) instrument allegedly got stuck and the device indicated that the blade might be exposed. The instrument was removed and replaced with a new one. There was bleeding that occurred due to the issue but the patient was reportedly doing well now. The surgical delay was less than 15 minutes. Intuitive surgical, inc. (isi) followed up with the surgeon and obtained the following information: the instrument was inspected before use and there was no damage seen. The vse instrument was working properly before a "blade exposed" error occurred. The surgeon was trying to seal and cut mesocolon when the issue occurred. The total blood loss for the procedure was 300 ml and the vse instrument issue allegedly contributed to 150 ml of the bleeding. Prior to removing the vse instrument, the two ends of the vessel were grabbed with laparoscopic forceps and the vse instrument was removed with force. It was explained that the vse instrument had to be removed forcefully as it was not obeying the commands of the surgeon. A backup vse instrument was used without any issues to complete the procedure.
 
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Brand NameENDOWRIST
Type of DeviceVESSEL SEALER EXTEND
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 Key13426959
MDR Text Key289443704
Report Number2955842-2022-10164
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K173337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422-01
Device Catalogue Number480422
Device Lot NumberM90210803 0072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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