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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LARGE NEEDLE DRIVER

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INTUITIVE SURGICAL, INC ENDOWRIST; LARGE NEEDLE DRIVER Back to Search Results
Model Number 470006-12
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc.(isi) received the large needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of frayed grip cable at the distal end to be related to the customer reported complaint.The frayed cable strands stuck out at the wrist.The root cause of frayed distal grip cables is attributed to a component failure.An additional observation, which was not reported by the site, was that the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.055¿ - 0.116¿ in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions instrument main tube is typically attributed to mishandling/misuse.A review of the instrument log for the large needle driver instrument (part # 470006-12 /lot# n11200921-0183) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021, on system (b)(4).The instrument had 4 uses remaining after last use.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.This complaint is a reportable event due to the following conclusion: failure analysis acknowledged 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.
 
Event Description
It was reported that during a da vinci-assisted nipple sparing malignant mastectomy with reconstruction surgical procedure, the large needle driver was found to have a cable cut.A backup instrument of the same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that no fragment fell into the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications.
 
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Brand Name
ENDOWRIST
Type of Device
LARGE NEEDLE DRIVER
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 Key13691437
MDR Text Key296849753
Report Number2955842-2022-10517
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112151
UDI-Public(01)00886874112151(10)N11200921
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 02/08/2022
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 Number470006-12
Device Catalogue Number470006
Device Lot NumberN11200921 0183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2022
Initial Date FDA Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2020
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
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