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Model Number 480422-01
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the vessel sealer extend (vse) instrument involved with this complaint and completed the device evaluation. The instrument was found to have a dislodged blade failure based on log review. A visual inspection revealed that the blade was not exposed outside of the blade garage. No conductor wire damage or snake wrist damage was found. There was no bio debris found on the instruments tip. A review of the logs revealed one blade exposed failure. The root cause of the dislodged instruments blade is typically attributed to mishandling/misuse. The instrument was placed and driven on an in-house system. The instrument passed the self-test homing. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly and the instrument passed the knife slot test. Additionally, the instrument was found to have a dislodged ceramic dot of the grip at the distal end. The dislodged material was not returned with the instrument. Root cause of this failure is attributed to mishandling/misuse. A review of the instrument log was performed. Per the review, the vse instrument, sn: (b)(4) was used on system (b)(4) on (b)(6) 2022 with 0 lives remaining. A review of the site's complaint history identified no other complaints related to the instrument and/or this event. No image or procedure video was provided for review. Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end). 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, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but 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.
Event Description
It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, about 15 minutes into using the vessel sealer extend (vse) instrument to seal tissue, the customer received an alert that the blade was exposed. The procedure was continuing as planned with no reported injury. Follow up was performed with the customer and additional information was obtained. The robotics coordinator stated that the instrument involved was not inspected prior to use, and that they had not been advised to examine each disposable instrument after opening. Per the customer's response, the issue occurred during sealing and cutting; the instrument was not sealing properly/adequately. The customer further stated that the surgeon stated he noticed the sealing was good at times, and not so good at other times. Then he reportedly took a decent bite of thick tissue and the robot screen said ¿blade may be exposed, remove instrument¿ and that is what the team did. The surgeon stated the tones were like they always are. As to whether tissue was cut that was not fully sealed, the customer stated that was unlikely since the surgeon was paying close attention to the tension, tones and sealing/cutting features; also due to the surgeon's familiarity with the instrument, it was unlikely that the target tissue was under tension. The customer stated the surgeon does not know what caused the issue with the vse, and the procedure was completed without further incident.
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Manufacturer (Section D)
3410 central expressway
santa clara CA
Manufacturer (Section G)
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
MDR Report Key14235024
MDR Text Key290266769
Report Number2955842-2022-11287
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422-01
Device Catalogue Number480422
Device Lot NumberM91211123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberISIFA2022-01-C

Patient Treatment Data
Date Received: 04/28/2022 Patient Sequence Number: 1