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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST MONOPOLAR CURVED SCISSORS HOT SHEARS

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INTUITIVE SURGICAL, INC. ENDOWRIST MONOPOLAR CURVED SCISSORS HOT SHEARS Back to Search Results
Model Number 400180
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/03/2018
Event Type  malfunction  
Event Description
A patient underwent surgery including robotic-assisted laparoscopic lysis of adhesions and bladder diverticulectomy. Following surgery, a ct abd/pelvis revealed the presence of a questionable foreign body; it was noted it could represent the tip cover of the monopolar curved scissors.
 
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Brand NameENDOWRIST MONOPOLAR CURVED SCISSORS
Type of DeviceHOT SHEARS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd.
sunnyvale CA
MDR Report Key7186482
MDR Text Key97370118
Report NumberMW5074540
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 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
Was Device Available for Evaluation? No
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? No
Type of Device Usage

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