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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HARMONIC ACE CURVED SHEARS HARMONIC SCALPEL SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. HARMONIC ACE CURVED SHEARS HARMONIC SCALPEL SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480275
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 12/09/2021
Event Type  malfunction  
Event Description
Davinci harmonic ace curved shears malfunctioned while in use. The white piece inside of the harmonic cutting tip completely split in half. Fda safety report id# (b)(4).
 
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Brand NameHARMONIC ACE CURVED SHEARS HARMONIC SCALPEL
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13002371
MDR Text Key282358945
Report NumberMW5106027
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 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480275
Device Catalogue Number480275
Device Lot NumberL90211018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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