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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 470405-06
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the instrument tip was broken. The procedure was completed as planned with no report of patient harm, adverse outcome or injury. The force bipolar instrument is a multi-use instrument with bipolar energy capability. This instrument is designed for dissection, grasping, retraction, and bipolar coagulation of tissue. This instrument allows the user to temporarily apply a strong grip mode, depending on surgical needs. Intuitive surgical, inc. (isi) has attempted to follow up to obtain additional information, however, no further details have been received as of date of this report.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the customer reported complaint. The instrument was found to have a broken grip at the grip base. A piece approximately 0. 04" x 0. 37" was found to be broken off the distal end. The broken piece was not returned. The following was found during the device evaluation, but is not related to the reportable finding: visual inspection of the conductor wires and insulation found no physical damage. An electrical continuity test was performed and passed. The instrument was not placed on an in-house system due to its damaged condition and inability to fit through the cannula. A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event. No images or procedure video were provided for review. A review of the device logs for the force bipolar (470405-06 | n10190930 0117) associated with this event has been performed. Per this review of the logs, the force bipolar was last used on (b)(6) 2020 on system (b)(4), with 6 uses remaining. Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient. 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 and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
 
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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 Key13835344
MDR Text Key297248837
Report Number2955842-2022-10696
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470405-06
Device Catalogue Number470405
Device Lot NumberN10190930 0117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2019
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

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