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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 Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the force bipolar instrument and performed a device evaluation. Failure analysis confirmed the reported issue. The instrument was found to have a severely bent grip tip located at the conductor wire cable groove. The side piece was sticking outwards causing the grip to interfere with the cannula. As a result, the instrument would get stuck. The root cause of bent-severely instrument grips -tips is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the device logs for the force bipolar (part# 471405-06| lot-sequence# n12210705-0076) associated with this event has been performed. Per this review of the logs, the force bipolar was last used on (b)(6) 2022 during a nephrectomy procedure on system serial# (b)(4). No image or video clip for the reported event was submitted for review. This complaint is being classified as a reportable event due to the following conclusion: the instrument could not be removed from the cannula /trocar due to a severely bent grip. 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.
 
Event Description
It was reported that after a da vinci-assisted surgical procedure, the force bipolar instrument was stuck in the trocar and the jaws could not be closed. Site had to remove along with trocar. The procedure was completed as planned with no report of patient harm, adverse outcome or injury.
 
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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 Key13895354
MDR Text Key288057410
Report Number2955842-2022-10760
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,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberN12210705 0076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2021
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: 03/24/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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