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

Model Number JS440

Device Problem Problem with Sterilization (1596)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event 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
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP, INC. ; PA
• MDR Report Key: 11921821
• MDR Text Key: 254084011
• Report Number: MW5101653
• Device Sequence Number: 1
• Product Code: KCT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JS440
• Device Catalogue Number: JS440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1