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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE MEGA SUTURE CUT NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. INTUITIVE MEGA SUTURE CUT NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number 471309
Device Problem Dull, Blunt (2407)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Instrument was very dull despite having lives left to use. Had been processed 9 times. Fda safety report id# (b)(4).
 
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Brand NameINTUITIVE MEGA SUTURE CUT NEEDLE DRIVER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key12985332
MDR Text Key282265525
Report NumberMW5105985
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number471309
Device Lot NumberN11201027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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