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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS Back to Search Results
Lot Number N10180112
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/07/2018
Event Type  malfunction  
Event Description
During initial survey of abdomen laparoscopically, a black ring was noticed and removed. Upon further investigation, the black ring was found to be a piece of the intuitive instrument which had broken off and fallen into the pt's abdomen. This incident didn't cause pt harm or require any add'l intervention.
 
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Brand NameMONOPOLAR CURVED SCISSORS
Type of DeviceMONOPOLAR CURVED SCISSORS
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key7316471
MDR Text Key101715639
Report NumberMW5075663
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 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberN10180112
Was Device Available for Evaluation? Device Returned to Manufacturer
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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