MAUDE Adverse Event Report: WAGNER GMBH WAGNER STERISET; STERILIZATION TRAY

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.

• Brand Name: WAGNER STERISET
• Type of Device: STERILIZATION TRAY
• Manufacturer (Section D): WAGNER GMBH; simcon international llc; 1200 townline road; mundelein IL 60060
• MDR Report Key: 8154653
• MDR Text Key: 130048660
• Report Number: 8154653
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1.4404
• Device Catalogue Number: MDD 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 FDA: 12/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1