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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD/ V. MUELLER RONGUER, IVD CUSHING

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BD/ V. MUELLER RONGUER, IVD CUSHING Back to Search Results
Lot Number VINV03
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/04/2017
Event Type  malfunction  
Event Description
Information provided states: pituitary rongeur broke while dissecting and fell in wound. Surgeon was able to review the piece of instrumentation. (this is an fyi, as apparently these do break, but we wanted to make sure you were aware in case there is a problem with breakage. ).
 
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Brand NameRONGUER, IVD CUSHING
Type of DeviceRONGUER, IVD CUSHING
Manufacturer (Section D)
BD/ V. MUELLER
franklin lakes NJ 07417
MDR Report Key6237744
MDR Text Key64502615
Report NumberMW5067150
Device Sequence Number1
Product Code HAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberVINV03
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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