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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. HARMONIC ACE CURVED SHEARS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number M10170529
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2019
Event Type  malfunction  
Event Description
The tip of the harmonic ace curved shears broke off during a robotic case while inside the pt's abdomen. The tip and all other pieces were retrieved and removed from the pt. No pt harm or injury. (b)(6).
 
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Brand NameHARMONIC ACE CURVED SHEARS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key8535829
MDR Text Key142738756
Report NumberMW5086018
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 Risk Manager
Type of Report Initial
Report Date 02/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberM10170529
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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