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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 470205-17
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
An rma has been issued to the customer requesting to have the isi device returned; however, isi has not yet received the fenestrated bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.Product and event verification: a review of the device logs for the fenestrated bipolar forceps (part# 470205-17 | lot/serial# n132001060081) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2020 via system serial# (b)(4).There were 9 uses remaining after this last usage.There was no photo or video provided by the site for review.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 because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent energy transmission to tissue other than intended via the exposed conductor wire.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 during a da vinci-assisted surgical procedure, the customer stated that the fenestrated bipolar forceps (fbf) instrument was noted to have a broken cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) contacted the site to obtain additional information regarding this event.The only additional information provided was that it was the black cable that was broken.
 
Event Description
Refer to h10/h11 for follow-up information.
 
Manufacturer Narrative
Additional information can be found in the following section a and fields d10, g4, g7, h2, h3, h6, and h10.4307- intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.Fa found the primary failure of broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage were observed.The root cause of this failure is attributed to a component failure.
 
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Brand Name
ENDOWRIST
Type of Device
FENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
MDR Report Key11099740
MDR Text Key246228879
Report Number2955842-2020-11429
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112359
UDI-Public(01)00886874112359(10)N13200106
Combination Product (y/n)N
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/09/2020
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 Number470205-17
Device Catalogue Number470205
Device Lot NumberN13200106 0081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received01/07/2021
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
Patient Age58 YR
Patient Weight82
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