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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER

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INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER Back to Search Results
Model Number 470347-12
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that during central processing, the tip-up fenestrated grasper had a damaged shaft/tube. There was no report of patient involvement.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the reported complaint. Failure analysis found the primary failure of scratches on the main tube to be related to the customer reported complaint. The instrument was found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 096¿ - 0. 274" in length and were not aligned with the tube axis. The root cause of scratch marks /abrasions instrument main tube is typically attributed to the mishandling/misuse such as excessive contact with abrasive or hard surfaces during transport or reprocessing. 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 procedure video was provided for review. A review of the instrument log for the tip-up fenestrated grasper (part# 470347-12 / lot# u10210804/ sequence# 0024) associated with this event has been performed. Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 3 uses remaining. Based on this review, the instrument was not used in subsequent procedure(s) after the alleged event. There was no image or video clip submitted for review. This complaint is considered a reportable event 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 DeviceTIP-UP FENESTRATED GRASPER
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 Key13719464
MDR Text Key286922223
Report Number2955842-2022-10559
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
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
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347-12
Device Catalogue Number470347
Device Lot NumberU10210804 0024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
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 Treatment Data
Date Received: 03/10/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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