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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TURBETT SURGICAL TURBETT SURGICAL POD SURGICAL CONTAINER

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TURBETT SURGICAL TURBETT SURGICAL POD SURGICAL CONTAINER Back to Search Results
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  malfunction  
Event Description
Pt for right tka, filter on turbett surgical pod noted to have hole, instrument container returned to central processing for resterilization. Director of surgical services and operations manager of central processing aware and contacted turbett surgical. Operations manager, turbett surgical revietabs were added to help support the screen from distorting. All units within the hospital were updated. Wed the 3 units that produced holes in the filters. Two more.
 
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Brand NameTURBETT SURGICAL POD
Type of DeviceSURGICAL CONTAINER
Manufacturer (Section D)
TURBETT SURGICAL
MDR Report Key7292616
MDR Text Key100953834
Report NumberMW5075465
Device Sequence Number1
Product Code FRG
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 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2018
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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