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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAGNER GMBH WAGNER STERISET STERILIZATION TRAY

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WAGNER GMBH WAGNER STERISET STERILIZATION TRAY Back to Search Results
Model Number 1.4404
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2018
Event Type  malfunction  
Event Description
Upon completion of a surgery it was noted that the condensate drain valve from the steriset container had been missing since the sterilization process. This was not discovered because the automatic thermoloc sealed successfully as noted by the red blocks. Currently there is no indicator for when the valve is missing or even if there is an insufficient seal.
 
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Brand NameWAGNER STERISET
Type of DeviceSTERILIZATION TRAY
Manufacturer (Section D)
WAGNER GMBH
simcon international llc
1200 townline road
mundelein IL 60060
MDR Report Key8154653
MDR Text Key130048660
Report Number8154653
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1.4404
Device Catalogue NumberMDD 93/42/EWG
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2018
Event Location Hospital
Date Report to Manufacturer12/12/2018
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? No
Type of Device Usage

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