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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR

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INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR Back to Search Results
Model Number 471405-06
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the force bipolar instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the failure of broken grip tips. The instrument was found to have a broken grip at the grip base. A piece approximately 0. 18" x 0. 28" was found to be broken off the yaw pulley. The broken piece was returned with the instrument. No pieces were missing. The root cause of broken instrument grips tip is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws. System log review confirmed that the force bipolar instrument was last used on (b)(6) 2022 with one use remaining on system sk3387. A site history review was performed and no other complaints related to this product were identified. No image or procedure video was provided for review. This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci assisted procedure. The fragment was retrieved during the same procedure. At this time it is unknown what caused the breakage to occur.
 
Event Description
It was reported that during a da vinci-assisted sleeve gastrectomy the customer had issues with removing the force bipolar instrument was difficult to remove. Customer used emergency halt but still failed to remove instrument. The instrument was removed with the trocar. A piece of the instrument fell in the field but was retrieved. Procedure was completed with no patient harm. Intuitive surgical inc. (isi) follow up with the customer and confirmed fragments were retrieved from the patient. Customer visually inspected and confirmed since it was a single fragment that came off. No additional surgery was required to remove the fragment. An x-ray was conducted to confirm fragments were all retrieved. The instrument was inspected prior to the start of the procedure. The surgeon was attempting to excise tissue when the instrument got stuck. There were no instrument collisions. There was no harm to the patient and no tissue damage. No other information was available.
 
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Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
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 Key13832826
MDR Text Key292520027
Report Number2955842-2022-10678
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180351
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberN10210412 0016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2022
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2021
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: 03/20/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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