MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP JS CONTAINER; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	JS440
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Aesculap js series containers develop a layer of aluminum hydroxide on them after continued use in the sterrad.The powder builds up to the point of it falling onto sterile instruments inside the container.This is happening in several facilities throughout the country.Fda safety report id# (b)(4).

• Brand Name: AESCULAP JS CONTAINER
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP, INC. ; PA
• MDR Report Key: 11921821
• Report Number: MW5101653
• Device Sequence Number: 3037361
• Product Code: KCT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JS440
• Device Catalogue Number: JS440
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1