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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 Problems Break (1069); Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the force bipolar instrument involved with this complaint and completed the device evaluation. Failure analysis neither confirmed nor replicated the reported issue that there was ¿difficulty inserting/removing the instrument. ¿ the instrument was placed and driven on an in-house system. The instrument passed the recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. There was no difficulty inserting and removing the instrument. The instrument was found to have damage of the conductor wire¿s insulation. System log investigation: a review of the instrument log for the force bipolar instrument (pn: 470405-06, batch-sequence: t10191031- 0042) associated with this event has been performed. Per a review of the logs, the force bipolar was last used on (b)(6) 2020 on system sk1415. The alleged event occurred on the 6th use of the instrument. Site history review: a review of the site's complaint history does not show any additional complaints related to this product. Image/video review: no image/video investigation required as no image or video clip for the reported event was submitted for review. This complaint is being reported because damage to the conductor wire of the instrument could lead to unintended electrical discharge at a location other than intended. While there was no harm or injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system. The instrument was returned with 4 uses remaining and, therefore, was not expired. Implant date is blank because the product is not implantable. Initial reporter is blank because it is unknown if a report was submitted to the fda by the initial reporter. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
 
Event Description
It was reported that during a da vinci-assisted umbilical hernia repair surgical procedure, the customer experienced difficulty in inserting/removing the force bipolar instrument. The procedure was completed with no reported patient harm, injury, or adverse outcome.
 
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Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10469348
MDR Text Key220989365
Report Number2955842-2020-10824
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
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 NumberT10191031 0042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2019
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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