MAUDE Adverse Event Report: AESCULAP, INC. JN STERILIZATION CONTAINER WRAP, STERILIZATION

Model Number NJ SERIES

Device Problems Contamination (1120); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Aesculap jn series sterilization container form a build up of white powder on pans after several reuses. Several sites around country have had issues and aesculap has declared powder on inside of pan that contaminated surgical instruments safe to use. Fda safety report id # (b)(4).

• Brand Name: JN STERILIZATION CONTAINER
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): AESCULAP, INC. ; PA
• MDR Report Key: 12266785
• MDR Text Key: 264970764
• Report Number: MW5102942
• Device Sequence Number: 1
• Product Code: FRG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NJ SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

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