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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM

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INTUITIVE SURGICAL, INC. INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM Back to Search Results
Catalog Number 420205-13
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 08/31/2017
Event Type  malfunction  
Event Description
One side of the tip of an intuitive fenestrated bipolar forceps 8mm broke off during the procedure. The tip was retrieved. Intuitive sales rep (b)(6) notified and forceps shipped to him on (b)(6) 2017.
 
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Brand NameINTUITIVE
Type of DeviceFENESTRATED BIPOLAR FORCEPS 8MM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA
MDR Report Key7156812
MDR Text Key96240361
Report NumberMW5074311
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 09/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number420205-13
Device Lot NumberN10170120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2017
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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