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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; DAVINCI SI; FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST; DAVINCI SI; FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 420205-16
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested the fenestrated bipolar forceps instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.An image of the fenestrated bipolar forceps instrument related to this event was received.A review of the submitted image was performed by an isi failure analysis engineer.The following additional information was provided: it is hard to tell from the image, but it looks like the conductor wire insulation is damaged.A review of the logs showed the fenestrated bipolar forceps instrument (part# 420205-16 / lot# n10201130-868) was last used on (b)(6) 2021 during a procedure with system (b)(4).The fenestrated bipolar forceps instrument has 10 allotted uses and had 6 uses remaining.In addition, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported due to the following conclusion: a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.Although there was no patient injury reported, the failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that prior to the start of a da vinci-assisted nephrectomy surgical procedure, the customer discovered the front wire of the fenestrated bipolar forceps instrument was broken.There was no report of any fragments falling inside the patient.The procedure was completed with no reported injury.On 29-nov-2021, intuitive surgical, inc.(isi) performed follow-up with the customer and obtained additional information regarding the reported event.The instrument was reportedly inspected prior to use, and no issues were noted.The instrument did not collide with any other instrument or tool during the procedure.The customer reported that the conductor wire insulation was not damaged.It was confirmed that no fragments fell inside the patient during the procedure.There is no video recording of the procedure, but an image of the instrument damage was provided.
 
Event Description
Refer to h10/h11 for follow-up information.
 
Manufacturer Narrative
Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.D02 - intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary finding of the damaged conductor wire insulation to be related to the customer reported complaint.The instrument was found to have insulation damage on the conductor wire.The conductor wire insulation had a slash, exposing the electrical wires.There was no material missing.The electrical continuity test was performed and passed.The root cause of this failure is attributed to a component failure.
 
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Brand Name
ENDOWRIST; DAVINCI SI
Type of Device
FENESTRATED BIPOLAR FORCEPS
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 Key12960156
MDR Text Key286445001
Report Number2955842-2021-11692
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874111642
UDI-Public(01)00886874111642(10)N10201130
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number420205-16
Device Catalogue Number420205
Device Lot NumberN10201130 868
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received01/13/2022
Supplement Dates FDA Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2020
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 Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
Patient RaceAsian
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