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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL HARMONIC ACE CURVED SHEARS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480275
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 09/28/2021
Event Type  malfunction  
Event Description
During initial use of harmonic ace curved shears a relax pressure on blade message was noted then the device stopped working. Fda safety report id# (b)(4).
 
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Brand NameHARMONIC ACE CURVED SHEARS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL
sunnyvale CA 94086
MDR Report Key12751629
MDR Text Key280511291
Report NumberMW5105133
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 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480275
Device Catalogue Number480275
Device Lot NumberI90210730
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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